Intelligent Sexual Health Information Support System for Gynecological Cancer Patients

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 70 years
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Intelligent Sexual Health LillyBot Information Support System for Gynecological Cancer Patients: Development, Test and Evaluation of Longitudinal Effects

Conditions

Sexual and Reproductive Health, Gynecologic Cancer Survivors

Being tested

Intelligent Sexual Health Information Support with Proactive Nurse Researcher Contact, Intelligent Sexual Health Information Support with Safety-Triggered Nurse Researcher Contact, Usual Gynecologic Cancer Care

Keywords

gynecological cancer, sexual health, chatbot, mobile health

Medical subject headings

Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Intelligent Sexual Health Information Support with Proactive Nurse Researcher ContactOther

  The experimental group A will receivereceive the intelligent sexual health information support system along with proactive nurse researcher (registered nurse) contact.Data will be collected at baseline (T0), one month post-intervention (T1), and three months (T2) to evaluate the intervention's effectiveness.

• Intelligent Sexual Health Information Support with Safety-Triggered Nurse Researcher ContactOther

  The experimental group B will receive the intelligent sexual health information support system with nurse researcher contact only upon a triggered safety alert.Data will be collected at baseline (T0), one month post-intervention (T1), and three months (T2) to evaluate the intervention's effectiveness.

• Usual Gynecologic Cancer CareOther

  The control group will receive Usual Gynecologic Cancer Care.Data will be collected at baseline (T0), one month post-intervention (T1), and three months (T2) to evaluate the intervention's effectiveness.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The Women Sexual Distress

   The research project assessed changes in female sexual distress using a self-developed Female Sexual Distress Scale, developed with reference to the Female Sexual Distress Scale-Revised (FSDS-R) (Derogatis, Clayton, et al., 2008) and relevant literature. The scale consists of 22 items covering four dimensions of sexual health: comprehensive, physiological, psychological, and social. Items assess the frequency of emotional distress, including worry, depression, stress, low self-esteem, guilt, and distress. A 5-point Likert scale is used: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The total score ranges from 0 to 88, with higher scores indicating greater sexual distress. Cronbach's alpha was 0.96, and the Content Validity Index (CVI) was 1.00.

   Measured: Data were collected at baseline

2. The Women Sexual Distress

   The research project assessed changes in female sexual distress using a self-developed Female Sexual Distress Scale, developed with reference to the Female Sexual Distress Scale-Revised (FSDS-R) (Derogatis, Clayton, et al., 2008) and relevant literature. The scale consists of 22 items covering four dimensions of sexual health: comprehensive, physiological, psychological, and social. Items assess the frequency of emotional distress, including worry, depression, stress, low self-esteem, guilt, and distress. A 5-point Likert scale is used: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The total score ranges from 0 to 88, with higher scores indicating greater sexual distress. Cronbach's alpha was 0.96, and the Content Validity Index (CVI) was 1.00.

   Measured: Data were collected at 1 months after the Interventions.

3. The Women Sexual Distress

   The research project assessed changes in female sexual distress using a self-developed Female Sexual Distress Scale, developed with reference to the Female Sexual Distress Scale-Revised (FSDS-R) (Derogatis, Clayton, et al., 2008) and relevant literature. The scale consists of 22 items covering four dimensions of sexual health: comprehensive, physiological, psychological, and social. Items assess the frequency of emotional distress, including worry, depression, stress, low self-esteem, guilt, and distress. A 5-point Likert scale is used: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The total score ranges from 0 to 88, with higher scores indicating greater sexual distress. Cronbach's alpha was 0.96, and the Content Validity Index (CVI) was 1.00.

   Measured: Data were collected at 3 months after the Interventions.

4. Gynecological Cancer Sexual Knowledge

   The research project assessed gynecologic cancer sexual health knowledge using the Gynecologic Cancer Sexual Health Knowledge Scale developed by Lee et al. (2020). The scale assesses women's knowledge of gynecologic cancer, its treatment, and their effects on sexual health and management. It consists of 22 multiple-choice items covering four dimensions: basic concepts of sexuality, effects of gynecologic cancer on sexual health, effects of gynecologic cancer treatment on sexual health, and management of sexual health problems related to gynecologic cancer. Each item has three response options: true, false, and don't know. Correct answers receive 1 point; incorrect and "don't know" responses receive 0 points. The total score ranges from 0 to 22, with higher scores indicating greater sexual health knowledge. The Kuder-Richardson Formula 20 was 0.81, Cronbach's alpha was 0.77, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at baseline

5. Gynecological Cancer Sexual Knowledge

   The research project assessed gynecologic cancer sexual health knowledge using the Gynecologic Cancer Sexual Health Knowledge Scale developed by Lee et al. (2020). The scale assesses women's knowledge of gynecologic cancer, its treatment, and their effects on sexual health and management. It consists of 22 multiple-choice items covering four dimensions: basic concepts of sexuality, effects of gynecologic cancer on sexual health, effects of gynecologic cancer treatment on sexual health, and management of sexual health problems related to gynecologic cancer. Each item has three response options: true, false, and don't know. Correct answers receive 1 point; incorrect and "don't know" responses receive 0 points. The total score ranges from 0 to 22, with higher scores indicating greater sexual health knowledge. The Kuder-Richardson Formula 20 was 0.81, Cronbach's alpha was 0.77, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at 1 months after the Interventions.

6. Gynecological Cancer Sexual Knowledge

   The research project assessed gynecologic cancer sexual health knowledge using the Gynecologic Cancer Sexual Health Knowledge Scale developed by Lee et al. (2020). The scale assesses women's knowledge of gynecologic cancer, its treatment, and their effects on sexual health and management. It consists of 22 multiple-choice items covering four dimensions: basic concepts of sexuality, effects of gynecologic cancer on sexual health, effects of gynecologic cancer treatment on sexual health, and management of sexual health problems related to gynecologic cancer. Each item has three response options: true, false, and don't know. Correct answers receive 1 point; incorrect and "don't know" responses receive 0 points. The total score ranges from 0 to 22, with higher scores indicating greater sexual health knowledge. The Kuder-Richardson Formula 20 was 0.81, Cronbach's alpha was 0.77, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at 3 months after the Interventions.

7. Gynecological Cancer Sexual Attitudes

   The research project assessed attitudes toward sexual health using the Gynecologic Cancer Sexual Attitudes Scale developed by Lee et al. (2020). The scale assesses women's subjective attitudes and perceptions regarding gynecologic cancer, its treatment, sexual health, and sexual life. It consists of 25 items covering five dimensions: attitudes toward sexual communication between partners, perceptions of sexual relationships in couples with gynecologic cancer (intimate relationships), perceptions of body image after treatment, attitudes toward sexual health education for gynecologic cancer, and perceptions of gynecologic cancer and sexuality. A 5-point Likert scale is used, ranging from 5 = strongly agree to 1 = strongly disagree. Higher scores indicate more positive attitudes toward sexual health. Test-retest reliability was 0.92, Cronbach's alpha was 0.90, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at baseline

8. Gynecological Cancer Sexual Attitudes

   The research project assessed attitudes toward sexual health using the Gynecologic Cancer Sexual Attitudes Scale developed by Lee et al. (2020). The scale assesses women's subjective attitudes and perceptions regarding gynecologic cancer, its treatment, sexual health, and sexual life. It consists of 25 items covering five dimensions: attitudes toward sexual communication between partners, perceptions of sexual relationships in couples with gynecologic cancer (intimate relationships), perceptions of body image after treatment, attitudes toward sexual health education for gynecologic cancer, and perceptions of gynecologic cancer and sexuality. A 5-point Likert scale is used, ranging from 5 = strongly agree to 1 = strongly disagree. Higher scores indicate more positive attitudes toward sexual health. Test-retest reliability was 0.92, Cronbach's alpha was 0.90, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at 1 months after the Interventions.

9. Gynecological Cancer Sexual Attitudes

   The research project assessed attitudes toward sexual health using the Gynecologic Cancer Sexual Attitudes Scale developed by Lee et al. (2020). The scale assesses women's subjective attitudes and perceptions regarding gynecologic cancer, its treatment, sexual health, and sexual life. It consists of 25 items covering five dimensions: attitudes toward sexual communication between partners, perceptions of sexual relationships in couples with gynecologic cancer (intimate relationships), perceptions of body image after treatment, attitudes toward sexual health education for gynecologic cancer, and perceptions of gynecologic cancer and sexuality. A 5-point Likert scale is used, ranging from 5 = strongly agree to 1 = strongly disagree. Higher scores indicate more positive attitudes toward sexual health. Test-retest reliability was 0.92, Cronbach's alpha was 0.90, and the Content Validity Index (CVI) was 0.94 (Lee et al., 2020).

   Measured: Data were collected at 3 months after the Interventions.

10. Sexual Self-Efficacy

    The research project assessed sexual self-efficacy using the Gynecologic Cancer Sexual Self-Efficacy Scale developed by Lee et al. (2019). The scale evaluates self-efficacy related to sexual health among women with gynecologic cancer and consists of 27 items covering three dimensions: self-efficacy in promoting sexual physiological health, self-efficacy in promoting sexual psychological health, and sexual communication self-efficacy. A 5-point response scale is used to assess confidence in performing each ability, ranging from 0 = no confidence at all to 100 = very confident. Higher scores indicate greater sexual self-efficacy. The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.98 and a Content Validity Index (CVI) of 0.88 (Lee et al., 2019).

    Measured: Data were collected at baseline

11. Sexual Self-Efficacy

    The research project assessed sexual self-efficacy using the Gynecologic Cancer Sexual Self-Efficacy Scale developed by Lee et al. (2019). The scale evaluates self-efficacy related to sexual health among women with gynecologic cancer and consists of 27 items covering three dimensions: self-efficacy in promoting sexual physiological health, self-efficacy in promoting sexual psychological health, and sexual communication self-efficacy. A 5-point response scale is used to assess confidence in performing each ability, ranging from 0 = no confidence at all to 100 = very confident. Higher scores indicate greater sexual self-efficacy. The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.98 and a Content Validity Index (CVI) of 0.88 (Lee et al., 2019).

    Measured: Data were collected at 1 months after the Interventions.

12. Sexual Self-Efficacy

    The research project assessed sexual self-efficacy using the Gynecologic Cancer Sexual Self-Efficacy Scale developed by Lee et al. (2019). The scale evaluates self-efficacy related to sexual health among women with gynecologic cancer and consists of 27 items covering three dimensions: self-efficacy in promoting sexual physiological health, self-efficacy in promoting sexual psychological health, and sexual communication self-efficacy. A 5-point response scale is used to assess confidence in performing each ability, ranging from 0 = no confidence at all to 100 = very confident. Higher scores indicate greater sexual self-efficacy. The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.98 and a Content Validity Index (CVI) of 0.88 (Lee et al., 2019).

    Measured: Data were collected at 3 months after the Interventions.

13. Diversity of sexual activity

    The research project assessed sexual activity using the Diversity of Sexual Activity Scale (DSA) developed by Lee et al. (2020). The scale evaluates the types of sexual activities practiced by individuals or with their partners. It includes 12 types of sexual activities. Participants indicate the intimate activities they engage in, the frequency of each activity, and their satisfaction with each activity. Frequency is assessed using a 5-point scale ranging from 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, to 4 = always. Satisfaction is assessed using a 7-point scale ranging from 1 = very dissatisfied to 7 = very satisfied, with higher scores indicating greater satisfaction with the activity. Cronbach's alpha was 0.976 in a postpartum sample (Lee \& Tsai, 2012) and 0.921 in women with gynecologic cancer (Lee et al., 2020).

    Measured: Data were collected at baseline

14. Diversity of sexual activity

    The research project assessed sexual activity using the Diversity of Sexual Activity Scale (DSA) developed by Lee et al. (2020). The scale evaluates the types of sexual activities practiced by individuals or with their partners. It includes 12 types of sexual activities. Participants indicate the intimate activities they engage in, the frequency of each activity, and their satisfaction with each activity. Frequency is assessed using a 5-point scale ranging from 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, to 4 = always. Satisfaction is assessed using a 7-point scale ranging from 1 = very dissatisfied to 7 = very satisfied, with higher scores indicating greater satisfaction with the activity. Cronbach's alpha was 0.976 in a postpartum sample (Lee \& Tsai, 2012) and 0.921 in women with gynecologic cancer (Lee et al., 2020).

    Measured: Data were collected at 1 months after the Interventions.

15. Diversity of sexual activity

    The research project assessed sexual activity using the Diversity of Sexual Activity Scale (DSA) developed by Lee et al. (2020). The scale evaluates the types of sexual activities practiced by individuals or with their partners. It includes 12 types of sexual activities. Participants indicate the intimate activities they engage in, the frequency of each activity, and their satisfaction with each activity. Frequency is assessed using a 5-point scale ranging from 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, to 4 = always. Satisfaction is assessed using a 7-point scale ranging from 1 = very dissatisfied to 7 = very satisfied, with higher scores indicating greater satisfaction with the activity. Cronbach's alpha was 0.976 in a postpartum sample (Lee \& Tsai, 2012) and 0.921 in women with gynecologic cancer (Lee et al., 2020).

    Measured: Data were collected at 3 months after the Interventions.

16. Sexual Satisfaction

    The research project assessed female sexual satisfaction using the New Sexual Satisfaction Scale-Short Form, Chinese version (NSSS-SC), translated by Wu et al. (2023). The scale consists of 12 items and uses a 5-point Likert scale ranging from 1 = not at all satisfied to 5 = extremely satisfied. The total score ranges from 12 to 60, with higher scores indicating greater satisfaction with sexual life. Confirmatory factor analysis showed good model fit (CFI = 0.999, TLI = 0.999, SRMR = 0.055, RMSEA = 0.014). The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.96 (Wu et al., 2023).

    Measured: Data were collected at baseline

17. Sexual Satisfaction

    The research project assessed female sexual satisfaction using the New Sexual Satisfaction Scale-Short Form, Chinese version (NSSS-SC), translated by Wu et al. (2023). The scale consists of 12 items and uses a 5-point Likert scale ranging from 1 = not at all satisfied to 5 = extremely satisfied. The total score ranges from 12 to 60, with higher scores indicating greater satisfaction with sexual life. Confirmatory factor analysis showed good model fit (CFI = 0.999, TLI = 0.999, SRMR = 0.055, RMSEA = 0.014). The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.96 (Wu et al., 2023).

    Measured: Data were collected at 1 months after the Interventions.

18. Sexual Satisfaction

    The research project assessed female sexual satisfaction using the New Sexual Satisfaction Scale-Short Form, Chinese version (NSSS-SC), translated by Wu et al. (2023). The scale consists of 12 items and uses a 5-point Likert scale ranging from 1 = not at all satisfied to 5 = extremely satisfied. The total score ranges from 12 to 60, with higher scores indicating greater satisfaction with sexual life. Confirmatory factor analysis showed good model fit (CFI = 0.999, TLI = 0.999, SRMR = 0.055, RMSEA = 0.014). The scale demonstrated good internal consistency, with a Cronbach's alpha of 0.96 (Wu et al., 2023).

    Measured: Data were collected at 3 months after the Interventions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted31 Aug 2026
2. Study start17 Jun 2026
3. Primary completionDec 2026 (estimated)
4. Study completionDec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (32)Papers the sponsor has linked to this study.
• Other trials for Sexual and Reproductive HealthStudies of the same condition, open and under way.
• 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.