Reproductive HealthNCT06757465
Women Diagnosed With Cancer & Reproductive Concerns & Watson's Human Caring Theory &Counselling
A study testing Counseling education based on Watson's Theory of Human Caring in people with Reproductive Health, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Counseling education based on Watson's Theory of Human Caring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Sep 2024
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being of reproductive age between 18-45 years,
- Not starting chemotherapy and radiotherapy treatment,
- Having no vision, hearing or mental problems,
- Knowing how to read and write and speaking Turkish,
- Agreeing to participate in the study voluntarily.
Who cannot join
- Being in menopause,
- Having had a hysterectomy,
- Being in Stage IV of the cancer diagnosed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed With Cancer: A Randomized Controlled Study
This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns.
Read the detailed description
Reproductive concerns, one of the important problems affecting the quality of life of women diagnosed with cancer, is becoming a critical problem that needs to be addressed with both psychological and social dimensions when combined with concerns about the future. This study aims to examine the effect of counseling on reproductive concerns in women diagnosed with cancer, based on Watson's Human Caring Theory and an interview guide prepared by the researcher.
A randomized controlled experimental study with a pre-test-post-test design was conducted to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on reproductive concerns. The universe of the study consisted of female patients diagnosed with cancer between the ages of 18-45 who applied to the Department of Obstetrics and Gynecology (Family Planning and Infertility Research and Application Center and Gynecology Oncology Clinic), Oncology Department and General Surgery Department of Ege University Hospital. The research was conducted in the designated clinics of Ege University Faculty of Medicine Hospital between January 1, 2024 and September 15, 2024. The sample of the research consisted of 50 women diagnosed with cancer, 25 intervention and 25 controls. In the data collection process of the study, a "Participant Information Form" and a " "Reproductive Concerns After Cancer Scale" will be administered in the pre-test for both intervention and control groups. For the control group, four weeks after the pre-test, the "Reproductive Concerns After Cancer Scale" and the "Patient Satisfaction Evaluation Form According to Watson's Healing Processes" will be applied. For the intervention group, counseling sessions grounded in Watson's Human Caring Theory will be conducted in three sessions, and a post-test will be administered four weeks later.
The study, it was determined that the reproductive concerns levels of women in the intervention group who received counseling education based on Watson's Theory of Human Caring were significantly lower (p < 0.05). The patient satisfaction assessment scores based on the improvement processes showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). The Patient Satisfaction Evaluation Form scores based on Watson's Processes of Healing showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). Counseling based on Watson's Theory of Human Caring was found to reduce reproductive concerns and improve patient satisfaction based on Watson's Processes of Healing in women diagnosed with cancer.
- Conditions
- Reproductive Health
- Being tested
- Counseling education based on Watson's Theory of Human Caring
- Keywords
- Cancer, Counseling, Reproductive Concerns, Women
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling education based on Watson's Theory of Human CaringOther
In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms (Zoom, Microsoft Teams, WhatsApp video call) within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Telehealth applications provided easy access to the participants during the counseling process and supported the continuity of individual counseling services.
| Study group | Role | What they receive |
|---|---|---|
| Counseling for reproductive concerns in women diagnosed with cancer | Experimental | In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Immediately after the sessions of counseling training based on Watson IBC were applied, the "the Reproductive Concerns After Cancer Scale " and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healin" were applied as interim tests to measure the effect of counseling on reproductive concerns levels of the patients. These tests were repeated 4 weeks after the end of the training. Receives: Other: Counseling education based on Watson's Theory of Human Caring |
| Control | No intervention | No intervention was made to the participants in the control group after the pre-test was applied as part of the data collection process. The women in the control group received the standard counseling service routinely applied in the clinic. After the patients were met, detailed information about the study was given, their informed consent was obtained and the contact information of the researcher was provided to them. 4 weeks after the pre-test, "the Reproductive Concerns After Cancer Scale" and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing" were applied to the participants in the control group as a post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Reproductive Concerns After Cancer Scale
The scale assesses fertility and parenting concerns. It consists of 18 items. The lowest total score from the scale is 18 and the highest is 90. As the score increases, the level of reproductive concerns increases.
Measured: Change from before implementation and 4th week of practice.
The Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing
It is used to evaluate nursing care based on Watson's Human Caring Theory. It consists of 6 questions. The total highest score from this evaluation form is 35, and the lowest score is five.
Measured: Change from 4th week of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2024
- Primary completion8 Feb 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single-blind, randomized controlled clinical trial, parallel
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruken Yağız Altıntaş, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757465
- Sponsor's protocol ID
- E-1669200
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers plan to publish it as an article.
Publications
Qiu J, Tang L, Li P, Fu J. An investigation into the reproductive concerns of young women with breast cancer. Asia Pac J Oncol Nurs. 2022 Mar 24;9(6):100055. doi: 10.1016/j.apjon.2022.03.007. eCollection 2022 Jun.
PubMed 35615663Xiao Y, Li J, Lei J, Li X, Hu M, Zhao J, Han L, Chen O. Qualitative study of the fertility information support experiences of young breast cancer patients. Eur J Oncol Nurs. 2023 Feb;62:102275. doi: 10.1016/j.ejon.2023.102275. Epub 2023 Jan 25.
PubMed 36716530Young K, Shliakhtsitsava K, Natarajan L, Myers E, Dietz AC, Gorman JR, Martinez ME, Whitcomb BW, Su HI. Fertility counseling before cancer treatment and subsequent reproductive concerns among female adolescent and young adult cancer survivors. Cancer. 2019 Mar 15;125(6):980-989. doi: 10.1002/cncr.31862. Epub 2018 Nov 29.
PubMed 30489638
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed With Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06757465
- Acronym / sponsor ID
- E-1669200
- Conditions
- Reproductive Health
- Keywords
- Cancer, Counseling, Reproductive Concerns, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 3 Jan 2025 (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.
This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns.
Detailed description
Reproductive concerns, one of the important problems affecting the quality of life of women diagnosed with cancer, is becoming a critical problem that needs to be addressed with both psychological and social dimensions when combined with concerns about the future. This study aims to examine the effect of counseling on reproductive concerns in women diagnosed with cancer, based on Watson's Human Caring Theory and an interview guide prepared by the researcher.
A randomized controlled experimental study with a pre-test-post-test design was conducted to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on reproductive concerns. The universe of the study consisted of female patients diagnosed with cancer between the ages of 18-45 who applied to the Department of Obstetrics and Gynecology (Family Planning and Infertility Research and Application Center and Gynecology Oncology Clinic), Oncology Department and General Surgery Department of Ege University Hospital. The research was conducted in the designated clinics of Ege University Faculty of Medicine Hospital between January 1, 2024 and September 15, 2024. The sample of the research consisted of 50 women diagnosed with cancer, 25 intervention and 25 controls. In the data collection process of the study, a "Participant Information Form" and a " "Reproductive Concerns After Cancer Scale" will be administered in the pre-test for both intervention and control groups. For the control group, four weeks after the pre-test, the "Reproductive Concerns After Cancer Scale" and the "Patient Satisfaction Evaluation Form According to Watson's Healing Processes" will be applied. For the intervention group, counseling sessions grounded in Watson's Human Caring Theory will be conducted in three sessions, and a post-test will be administered four weeks later.
The study, it was determined that the reproductive concerns levels of women in the intervention group who received counseling education based on Watson's Theory of Human Caring were significantly lower (p < 0.05). The patient satisfaction assessment scores based on the improvement processes showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). The Patient Satisfaction Evaluation Form scores based on Watson's Processes of Healing showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). Counseling based on Watson's Theory of Human Caring was found to reduce reproductive concerns and improve patient satisfaction based on Watson's Processes of Healing in women diagnosed with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- a single-blind, randomized controlled clinical trial, parallel
| Arm | Type | Receives |
|---|---|---|
| Counseling for reproductive concerns in women diagnosed with cancer | Experimental | Other: Counseling education based on Watson's Theory of Human CaringIn this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Immediately after the sessions of counseling training based on Watson IBC were applied, the "the Reproductive Concerns After Cancer Scale " and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healin" were applied as interim tests to measure the effect of counseling on reproductive concerns levels of the patients. These tests were repeated 4 weeks after the end of the training. |
| Control | No intervention | –No intervention was made to the participants in the control group after the pre-test was applied as part of the data collection process. The women in the control group received the standard counseling service routinely applied in the clinic. After the patients were met, detailed information about the study was given, their informed consent was obtained and the contact information of the researcher was provided to them. 4 weeks after the pre-test, "the Reproductive Concerns After Cancer Scale" and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing" were applied to the participants in the control group as a post-test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being of reproductive age between 18-45 years,
- Not starting chemotherapy and radiotherapy treatment,
- Having no vision, hearing or mental problems,
- Knowing how to read and write and speaking Turkish,
- Agreeing to participate in the study voluntarily.
Key exclusion criteria (3 listed)
- Being in menopause,
- Having had a hysterectomy,
- Being in Stage IV of the cancer diagnosed.
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 |
|---|---|---|
| Counseling education based on Watson's Theory of Human CaringIn this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms (Zoom, Microsoft Teams, WhatsApp video call) within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Telehealth applications provided easy access to the participants during the counseling process and supported the continuity of individual counseling services. | Other | Counseling for reproductive concerns in women diagnosed with cancer |
Primary outcome
The Reproductive Concerns After Cancer Scale
Time frame: Change from before implementation and 4th week of practice.
The scale assesses fertility and parenting concerns. It consists of 18 items. The lowest total score from the scale is 18 and the highest is 90. As the score increases, the level of reproductive concerns increases.
The Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing
Time frame: Change from 4th week of practice.
It is used to evaluate nursing care based on Watson's Human Caring Theory. It consists of 6 questions. The total highest score from this evaluation form is 35, and the lowest score is five.
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 3 Jan 2025.
- Results publication: PubMed 35615663Qiu J, Tang L, Li P, Fu J. An investigation into the reproductive concerns of young women with breast cancer. Asia Pac J Oncol Nurs. 2022 Mar 24;9(6):100055. doi: 10.1016/j.apjon.2022.03.007. eCollection 2022 Jun.
- Results publication: PubMed 36716530Xiao Y, Li J, Lei J, Li X, Hu M, Zhao J, Han L, Chen O. Qualitative study of the fertility information support experiences of young breast cancer patients. Eur J Oncol Nurs. 2023 Feb;62:102275. doi: 10.1016/j.ejon.2023.102275. Epub 2023 Jan 25.
- Results publication: PubMed 30489638Young K, Shliakhtsitsava K, Natarajan L, Myers E, Dietz AC, Gorman JR, Martinez ME, Whitcomb BW, Su HI. Fertility counseling before cancer treatment and subsequent reproductive concerns among female adolescent and young adult cancer survivors. Cancer. 2019 Mar 15;125(6):980-989. doi: 10.1002/cncr.31862. Epub 2018 Nov 29.
- Individual participant dataSharing planned: Yes. The researchers plan to publish it as an article.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling education based on Watson's Theory of Human Caring in people with Reproductive Health, run by Ege University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 3 Jan 2025. 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 Turkey (Türkiye). 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?
The Reproductive Concerns After Cancer Scale (time frame: Change from before implementation and 4th week of practice.). The study lists 2 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 NCT06757465, which also lists 3 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 3 Jan 2025.