Sexual HealthNCT05771532
A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Gynecological Cancer Women
A study testing Received the GS-SHEP in people with Sexual Health, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual Health Education Program (GS-SHEP) in enhancing the sexual health of patients with gynecologic cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Sexual Health
- What is being tested?
- Received the GS-SHEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2017to 26 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks.
- 20 to 80 years old.
- Able to read, write, and speak Chinese.
- In order to comply with the spirit of gender sensitivity in this study, participants do not exclude whether they have a partner or different sexual orientation.
Who cannot join
- Presence of other malignant disease.
- Impaired mental function.
- sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity).
- History of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Gender-sensitive Sexual Health Education Program for Women With Gynecologic Cancer: A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Cervical Cancer Women
The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual Health Education Program (GS-SHEP) in enhancing the sexual health of patients with gynecologic cancer.
Read the detailed description
This study recruited patients with cervical cancer from the gynecological wards of a large-scale medical center in northern Taiwan. A total of 63 participants were divided into two groups. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual self-efficacy", and "sexual activity". Data were collected at baseline, one week, six weeks, four months, and seven months after intervention and analyzed using the statistical software SPSS 20.0.
- Conditions
- Sexual Health
- Being tested
- Received the GS-SHEP
- Keywords
- Sexual Self-efficacy, Sexuality, Health Education, Gender sensitivity, Transtheoretical Model
- Medical subject headings
- Sexuality, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Received the GS-SHEPBehavioural
The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," and "sexual self-efficacy."
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The experimental group (n=33) received a gender-sensitive and transtheoretical model (TTM)-based sexual health education program, which includes a 10-15-minute individual sexual health education and a sexual health pamphlet. The TTM-based sexual health education program was performed by a nurse educator with more than one year of clinical experience in gynecological nursing, who received formal training through enrollment in a course entitled " a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program." Receives: Behavioral: Received the GS-SHEP |
| The control group | No intervention | The control group (n=30) received a 10-15-minute routine sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. Both were provided by nursing staff with no formal training in " a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynecological Cancer Sexual Knowledge
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention.
Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Measured: Data were collected at baseline.
Gynecological Cancer Sexual Knowledge
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention.
Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Measured: Data were collected at 1 week after intervention.
Gynecological Cancer Sexual Knowledge
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention.
Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Measured: Data were collected at 6 weeks after intervention.
Gynecological Cancer Sexual Knowledge
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention.
Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Measured: Data were collected at 4 months after intervention.
Gynecological Cancer Sexual Knowledge
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention.
Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Measured: Data were collected at 6 months after intervention.
Gynecological Cancer Sexual Attitudes
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention.
Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Measured: Data were collected at baseline.
Gynecological Cancer Sexual Attitudes
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention.
Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Measured: Data were collected at 1 week after intervention.
Gynecological Cancer Sexual Attitudes
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention.
Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Measured: Data were collected at 6 weeks after intervention.
Gynecological Cancer Sexual Attitudes
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention.
Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Measured: Data were collected at 4 months after intervention.
Gynecological Cancer Sexual Attitudes
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention.
Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Measured: Data were collected at 6 months after intervention.
Gynecological Cancer Sexual self-efficacy
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention.
Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Measured: Data were collected at baseline.
Gynecological Cancer Sexual self-efficacy
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention.
Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Measured: Data were collected at 1 week after intervention.
Gynecological Cancer Sexual self-efficacy
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention.
Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Measured: Data were collected at 6 weeks after intervention.
Gynecological Cancer Sexual self-efficacy
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention.
Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Measured: Data were collected at 4 months after intervention.
Gynecological Cancer Sexual self-efficacy
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention.
Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Measured: Data were collected at 6 months after intervention.
Diversity of Sexual Activity
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Measured: Data were collected at baseline.
Diversity of Sexual Activity
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Measured: Data were collected at 1 week after intervention.
Diversity of Sexual Activity
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Measured: Data were collected at 6 weeks after intervention.
Diversity of Sexual Activity
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Measured: Data were collected at 4 months after intervention.
Diversity of Sexual Activity
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Measured: Data were collected at 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start26 Mar 2017
- Primary completion26 Jun 2018
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this two-group, controlled trial, 63 participants with cervical cancer were recruited from the gynecological wards of a large-scale medical center in northern Taiwan. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Tao LEE, Professor, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771532
- Sponsor's protocol ID
- 105-2629-S-182-002
- Status last verified
- Feb 2023
- First submitted
- 5 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kau YC, Liu FC, Kuo CF, Huang HJ, Li AH, Hsieh MY, Yu HP. Trend and survival outcome in Taiwan cervical cancer patients: A population-based study. Medicine (Baltimore). 2019 Mar;98(11):e14848. doi: 10.1097/MD.0000000000014848.
PubMed 30882680Hung H, You J, Chiang J, Hsieh P, Chiang S, Lai C, Tasi W, Yeh C, Chern Y, Hsu Y. Clinicopathological characteristics and outcomes of metachronous rectal cancer in patients with a history of cervical cancer with and without remote radiotherapy: Reports of 45 cases. Medicine (Baltimore). 2020 Jul 24;99(30):e21328. doi: 10.1097/MD.0000000000021328.
PubMed 32791729Donovan KA, Taliaferro LA, Alvarez EM, Jacobsen PB, Roetzheim RG, Wenham RM. Sexual health in women treated for cervical cancer: characteristics and correlates. Gynecol Oncol. 2007 Feb;104(2):428-34. doi: 10.1016/j.ygyno.2006.08.009. Epub 2006 Sep 26.
PubMed 17005248Lee J, Lin JB, Sun FJ, Chen YJ, Chang CL, Jan YT, Wu MH. Safety and efficacy of semiextended field intensity-modulated radiation therapy and concurrent cisplatin in locally advanced cervical cancer patients: An observational study of 10-year experience. Medicine (Baltimore). 2017 Mar;96(10):e6158. doi: 10.1097/MD.0000000000006158.
PubMed 28272204Guo C, Wang J, Wang Y, Qu X, Shi Z, Meng Y, Qiu J, Hua K. Novel artificial intelligence machine learning approaches to precisely predict survival and site-specific recurrence in cervical cancer: A multi-institutional study. Transl Oncol. 2021 May;14(5):101032. doi: 10.1016/j.tranon.2021.101032. Epub 2021 Feb 20.
PubMed 33618238Hogan, R.M. Human sexuality : A nursing perspective. Norwork : Appleton- Century-Crofs.1985.
Lee JT, Kuo HY, Huang KG, Lin JR, Chen ML. Diversity of sexual activity and correlates among women with gynecological cancer. Gynecol Oncol. 2020 Nov;159(2):503-508. doi: 10.1016/j.ygyno.2020.08.005. Epub 2020 Aug 27.
PubMed 32861538Lee JT, Yen HW. Randomized controlled evaluation of a theory-based postpartum sexual health education programme. J Adv Nurs. 2007 Nov;60(4):389-401. doi: 10.1111/j.1365-2648.2007.04395.x.
PubMed 17919161Lee JT, Tsai JL. Transtheoretical model-based postpartum sexual health education program improves women's sexual behaviors and sexual health. J Sex Med. 2012 Apr;9(4):986-96. doi: 10.1111/j.1743-6109.2011.02419.x. Epub 2011 Aug 3.
PubMed 21812937Lee, J. T. Bringing Gender Sensitivity into Sexual Health Education Program for Women with Gynecologic Cancer in Taiwan. Ministry of Science and Technology Research Program Report, 2017.Program Number：103-2511-S-182-005-MY2.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Gender-sensitive Sexual Health Education Program for Women With Gynecologic Cancer: A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Cervical Cancer Women
- ClinicalTrials.gov ID
- NCT05771532
- Acronym / sponsor ID
- 105-2629-S-182-002
- Conditions
- Sexual Health
- Keywords
- Sexual Self-efficacy, Sexuality, Health Education, Gender sensitivity, Transtheoretical Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual Health Education Program (GS-SHEP) in enhancing the sexual health of patients with gynecologic cancer.
Detailed description
This study recruited patients with cervical cancer from the gynecological wards of a large-scale medical center in northern Taiwan. A total of 63 participants were divided into two groups. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual self-efficacy", and "sexual activity". Data were collected at baseline, one week, six weeks, four months, and seven months after intervention and analyzed using the statistical software SPSS 20.0.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- For this two-group, controlled trial, 63 participants with cervical cancer were recruited from the gynecological wards of a large-scale medical center in northern Taiwan. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet).
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: Received the GS-SHEPThe experimental group (n=33) received a gender-sensitive and transtheoretical model (TTM)-based sexual health education program, which includes a 10-15-minute individual sexual health education and a sexual health pamphlet. The TTM-based sexual health education program was performed by a nurse educator with more than one year of clinical experience in gynecological nursing, who received formal training through enrollment in a course entitled " a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program." |
| The control group | No intervention | –The control group (n=30) received a 10-15-minute routine sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. Both were provided by nursing staff with no formal training in " a gender-sensitive and transtheoretical model (TTM)-based sexual health education training program." |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks.
- 20 to 80 years old.
- Able to read, write, and speak Chinese.
- In order to comply with the spirit of gender sensitivity in this study, participants do not exclude whether they have a partner or different sexual orientation.
Key exclusion criteria (4 listed)
- Presence of other malignant disease.
- Impaired mental function.
- sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity).
- History of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Received the GS-SHEPThe experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," and "sexual self-efficacy." | Behavioural | The experimental group |
Primary outcome
Gynecological Cancer Sexual Knowledge
Time frame: Data were collected at baseline.
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Gynecological Cancer Sexual Knowledge
Time frame: Data were collected at 1 week after intervention.
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Gynecological Cancer Sexual Knowledge
Time frame: Data were collected at 6 weeks after intervention.
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Gynecological Cancer Sexual Knowledge
Time frame: Data were collected at 4 months after intervention.
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Gynecological Cancer Sexual Knowledge
Time frame: Data were collected at 6 months after intervention.
The research project assessed changes in gynecological cancer sexual knowledge by Gynecological Cancer Sexual Knowledge(GCSKS) from baseline to 6 months after the intervention. Gynecological Cancer Sexual Knowledge was measured by a 23-item Gynecological Cancer Sexual Knowledge Scale (GCSKS). The GCSKS was designed to assess common conceptions about sexuality after gynecologic cancer treatment (Lee et al., 2020). The 23 items are statements about sexual health which cover four domains: 1) the basic concept of sex; 2) effects of gynecologic cancer treatment on sexual health; 3) effects of gynecologic cancer on sexual health; and 4) management of 0sexual problems. Statements are answered with true, false, or unknown; correct answers = 1; incorrect answers = 0. Total scores range from 0 to 23, with higher scores indicating better sexual knowledge.
Gynecological Cancer Sexual Attitudes
Time frame: Data were collected at baseline.
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Gynecological Cancer Sexual Attitudes
Time frame: Data were collected at 1 week after intervention.
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Gynecological Cancer Sexual Attitudes
Time frame: Data were collected at 6 weeks after intervention.
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Gynecological Cancer Sexual Attitudes
Time frame: Data were collected at 4 months after intervention.
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Gynecological Cancer Sexual Attitudes
Time frame: Data were collected at 6 months after intervention.
The research project assessed changes in gynecological cancer sexual attitudes by Gynecological Cancer Sexual Attitudes Scale (GCSAS) from baseline to 6 months after the intervention. Sexual attitudes were measured with a 25-item Gynecological Cancer Sexual Attitudes Scale (GCSAS) (Lee et al., 2020). The GCSAS measures sexual attitudes or ideas about five areas of sexuality: 1) sexual communication between couples; 2) sexual behavior with partner after gynecologic cancer; 3) perception of body image after cancer treatment; 4) the value of sexual health education; and 5) the impact of sex on the prognosis of gynecologic cancer. Each item is rated on a 5-point Likert-type scale with response options of "do not agree at all" (1) to "totally agree" (5). Total scores range from 25 to 125, with higher scores indicating more positive attitudes towards sex after gynecological cancer treatment.
Gynecological Cancer Sexual self-efficacy
Time frame: Data were collected at baseline.
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Gynecological Cancer Sexual self-efficacy
Time frame: Data were collected at 1 week after intervention.
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Gynecological Cancer Sexual self-efficacy
Time frame: Data were collected at 6 weeks after intervention.
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Gynecological Cancer Sexual self-efficacy
Time frame: Data were collected at 4 months after intervention.
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Gynecological Cancer Sexual self-efficacy
Time frame: Data were collected at 6 months after intervention.
The research project assessed changes in gynecological cancer sexual self-efficacy by Gynecological Cancer Sexual self-efficacy Scale from baseline to 6 months after the intervention. Cronbach α=0.94。( participants' confidence in their perceived ability to perform healthy postpartum sexual behaviors was measured by the questionnaire's 26-item Postpartum Sexual Self-efficacy subscale , with three dimensions: sexual psychology, sexual biology (e.g., self-care of perineal wound, vaginal lubrication), and sexual communication. Item responses are scored from 0 (no confidence) to 4 (very confident). Higher scores indicate greater confidence in perceived ability to perform a sexual behavior. Total scores range from 0 to 104; internal consistency (alpha coefficient) was 0.94.(Lee \& Yen, 2007)。
Diversity of Sexual Activity
Time frame: Data were collected at baseline.
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Diversity of Sexual Activity
Time frame: Data were collected at 1 week after intervention.
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Diversity of Sexual Activity
Time frame: Data were collected at 6 weeks after intervention.
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Diversity of Sexual Activity
Time frame: Data were collected at 4 months after intervention.
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Diversity of Sexual Activity
Time frame: Data were collected at 6 months after intervention.
Diversity of Sexual Activity is the alternative ways of sexual behavior or expression.The 12-item Diversity of Sexual Activities Scale (DSAS)is used to measure the alternative ways of sexual behavior, which includes 1) the occurrence of various sexual behaviors and 2) sexual satisfaction toward the specific sexual behaviors adopted before and after cancer therapy and has been demonstrated to be a valid measure of sexual activity for patients in Taiwan with gynecological cancer(Lee et al., 2020).The first 11 items of the DSAS are 11 sexual activities. Participants are asked to check each sexual activity adopted in the past six months since receiving cancer treatment and rate their satisfaction with the activity on a 7-point Likert scale ranging from 1 (not satisfied at all), 4 (acceptable), to 7 (very satisfied).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 30882680Kau YC, Liu FC, Kuo CF, Huang HJ, Li AH, Hsieh MY, Yu HP. Trend and survival outcome in Taiwan cervical cancer patients: A population-based study. Medicine (Baltimore). 2019 Mar;98(11):e14848. doi: 10.1097/MD.0000000000014848.
- Background: PubMed 32791729Hung H, You J, Chiang J, Hsieh P, Chiang S, Lai C, Tasi W, Yeh C, Chern Y, Hsu Y. Clinicopathological characteristics and outcomes of metachronous rectal cancer in patients with a history of cervical cancer with and without remote radiotherapy: Reports of 45 cases. Medicine (Baltimore). 2020 Jul 24;99(30):e21328. doi: 10.1097/MD.0000000000021328.
- Background: PubMed 17005248Donovan KA, Taliaferro LA, Alvarez EM, Jacobsen PB, Roetzheim RG, Wenham RM. Sexual health in women treated for cervical cancer: characteristics and correlates. Gynecol Oncol. 2007 Feb;104(2):428-34. doi: 10.1016/j.ygyno.2006.08.009. Epub 2006 Sep 26.
- Background: PubMed 28272204Lee J, Lin JB, Sun FJ, Chen YJ, Chang CL, Jan YT, Wu MH. Safety and efficacy of semiextended field intensity-modulated radiation therapy and concurrent cisplatin in locally advanced cervical cancer patients: An observational study of 10-year experience. Medicine (Baltimore). 2017 Mar;96(10):e6158. doi: 10.1097/MD.0000000000006158.
- Background: PubMed 33618238Guo C, Wang J, Wang Y, Qu X, Shi Z, Meng Y, Qiu J, Hua K. Novel artificial intelligence machine learning approaches to precisely predict survival and site-specific recurrence in cervical cancer: A multi-institutional study. Transl Oncol. 2021 May;14(5):101032. doi: 10.1016/j.tranon.2021.101032. Epub 2021 Feb 20.
- BackgroundHogan, R.M. Human sexuality : A nursing perspective. Norwork : Appleton- Century-Crofs.1985.
- Background: PubMed 32861538Lee JT, Kuo HY, Huang KG, Lin JR, Chen ML. Diversity of sexual activity and correlates among women with gynecological cancer. Gynecol Oncol. 2020 Nov;159(2):503-508. doi: 10.1016/j.ygyno.2020.08.005. Epub 2020 Aug 27.
- Background: PubMed 17919161Lee JT, Yen HW. Randomized controlled evaluation of a theory-based postpartum sexual health education programme. J Adv Nurs. 2007 Nov;60(4):389-401. doi: 10.1111/j.1365-2648.2007.04395.x.
- Background: PubMed 21812937Lee JT, Tsai JL. Transtheoretical model-based postpartum sexual health education program improves women's sexual behaviors and sexual health. J Sex Med. 2012 Apr;9(4):986-96. doi: 10.1111/j.1743-6109.2011.02419.x. Epub 2011 Aug 3.
- BackgroundLee, J. T. Bringing Gender Sensitivity into Sexual Health Education Program for Women with Gynecologic Cancer in Taiwan. Ministry of Science and Technology Research Program Report, 2017.Program Number：103-2511-S-182-005-MY2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Tao LEE, Professor principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Received the GS-SHEP in people with Sexual Health, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gynecological Cancer Sexual Knowledge (time frame: Data were collected at baseline.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771532, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.