Intelligent Sexual Health Information Support System for Gynecological Cancer Patients
2026年9月9日 更新者：Jian Tao Lee、Chang Gung Memorial Hospital
Intelligent Sexual Health LillyBot Information Support System for Gynecological Cancer Patients: Development, Test and Evaluation of Longitudinal Effects
This study aims to develop the LillyBot Smart Sexual Health Consultation System, designed to meet the sexual health learning and consultation needs of gynecological cancer (GC) patients in Taiwan.
Grounded in the Transtheoretical Model (TTM), this system integrates AI chatbot technology and mobile health (mHealth) to provide real-time, personalized sexual health education and consultations, ultimately improving the overall sexual well-being of GC patients.
研究概览
地位
招聘中
详细说明
In the first year, the study established the mHealth-assisted Patient-Reported Outcome Measurement (mHealth-assisted PROM) module and conducted a comprehensive sexual health needs assessment.
Based on these findings, the second-year study focuses on designing and developing the LillyBot system, ensuring its responsiveness to the specific needs of GC patients.
The third-year study will employ a prospective pretest-posttest randomized control group design with a single-blind approach.
A total of 90 GC patients will be recruited from a medical center in northern Taiwan and randomly assigned through stratified randomization into three groups.
The first experimental group will receive LillyBot-based sexual health consultations, while the second experimental group will receive online consultations with sexual health professionals.
The control group will receive online consultations with non-specialists.
Data will be collected at baseline (T0), one month post-intervention (T1), and three months (T2) to evaluate the intervention's effectiveness.
Primary outcomes will include sexual distress, sexual knowledge, sexual attitudes, sexual self-efficacy, sexual behaviors, and sexual satisfaction, allowing for a comprehensive assessment of changes over time.
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jian Tao LEE, Professor
- 电话号码：5197 886-03-2118800
- 邮箱：jtlee@gap.cgu.edu.tw
学习地点
-
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Guishan
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Taoyuan、Guishan、台湾、333
- 招聘中
- Cheng Gung Memorial Hospital
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接触：
- Jian Tao LEE, Professor
- 电话号码：5197 886-03-2118800
- 邮箱：jtlee@gap.cgu.edu.tw
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Women diagnosed with gynecologic cancer within 6 months prior to enrollment.
- Women receiving cancer treatment at the recruiting hospital.
- Aged 20 to 70 years, inclusive.
- Have a regular partner.
- Possesses and is able to use an internet-enabled mobile device (such as a smartphone or iPad).
- Able to clearly communicate and read/write in Mandarin or Taiwanese.
Exclusion Criteria:
- History of other malignant tumors.
- Intellectual disability or mental disorders.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：The control group
The control group will not use the system and will continue to receive usual gynecologic cancer care.
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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.
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实验性的：The experimental group A -Proactive Nurse Support Group
The experimental group A will receive the intelligent sexual health information support system along with proactive nurse researcher (registered nurse) contact.
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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.
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实验性的：The experimental group B -Alert-Triggered Nurse Support Group
The experimental group B will receive the intelligent sexual health information support system with nurse researcher contact only upon a triggered safety alert.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Women Sexual Distress
大体时间：Data were collected at baseline
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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.
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Data were collected at baseline
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The Women Sexual Distress
大体时间：Data were collected at 1 months after the Interventions.
|
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.
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Data were collected at 1 months after the Interventions.
|
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The Women Sexual Distress
大体时间：Data were collected at 3 months after the Interventions.
|
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.
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Data were collected at 3 months after the Interventions.
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Gynecological Cancer Sexual Knowledge
大体时间：Data were collected at baseline
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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).
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Data were collected at baseline
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Gynecological Cancer Sexual Knowledge
大体时间：Data were collected at 1 months after the Interventions.
|
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).
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Data were collected at 1 months after the Interventions.
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Gynecological Cancer Sexual Knowledge
大体时间：Data were collected at 3 months after the Interventions.
|
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).
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Data were collected at 3 months after the Interventions.
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Gynecological Cancer Sexual Attitudes
大体时间：Data were collected at baseline
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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).
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Data were collected at baseline
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Gynecological Cancer Sexual Attitudes
大体时间：Data were collected at 1 months after the Interventions.
|
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).
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Data were collected at 1 months after the Interventions.
|
|
Gynecological Cancer Sexual Attitudes
大体时间：Data were collected at 3 months after the Interventions.
|
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).
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Data were collected at 3 months after the Interventions.
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Sexual Self-Efficacy
大体时间：Data were collected at baseline
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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).
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Data were collected at baseline
|
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Sexual Self-Efficacy
大体时间：Data were collected at 1 months after the Interventions.
|
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).
|
Data were collected at 1 months after the Interventions.
|
|
Sexual Self-Efficacy
大体时间：Data were collected at 3 months after the Interventions.
|
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).
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Data were collected at 3 months after the Interventions.
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Diversity of sexual activity
大体时间：Data were collected at baseline
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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).
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Data were collected at baseline
|
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Diversity of sexual activity
大体时间：Data were collected at 1 months after the Interventions.
|
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).
|
Data were collected at 1 months after the Interventions.
|
|
Diversity of sexual activity
大体时间：Data were collected at 3 months after the Interventions.
|
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).
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Data were collected at 3 months after the Interventions.
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Sexual Satisfaction
大体时间：Data were collected at baseline
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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).
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Data were collected at baseline
|
|
Sexual Satisfaction
大体时间：Data were collected at 1 months after the Interventions.
|
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).
|
Data were collected at 1 months after the Interventions.
|
|
Sexual Satisfaction
大体时间：Data were collected at 3 months after the Interventions.
|
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).
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Data were collected at 3 months after the Interventions.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月17日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年8月26日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月31日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.