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Intelligent Sexual Health Information Support System for Gynecological Cancer Patients

2026년 9월 9일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Guishan
      • Taoyuan, Guishan, 대만, 333
        • 모병
        • Cheng Gung Memorial Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: The control group
The control group will not use the system and will continue to receive usual gynecologic cancer care.
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.
실험적: 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.
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.
실험적: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Women Sexual Distress
기간: Data were collected at baseline
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.
Data were collected at baseline
The Women Sexual Distress
기간: 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.
Data were collected at 1 months after the Interventions.
The Women Sexual Distress
기간: 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.
Data were collected at 3 months after the Interventions.
Gynecological Cancer Sexual Knowledge
기간: Data were collected at baseline
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).
Data were collected at baseline
Gynecological Cancer Sexual Knowledge
기간: 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).
Data were collected at 1 months after the Interventions.
Gynecological Cancer Sexual Knowledge
기간: 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).
Data were collected at 3 months after the Interventions.
Gynecological Cancer Sexual Attitudes
기간: Data were collected at baseline
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).
Data were collected at baseline
Gynecological Cancer Sexual Attitudes
기간: 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).
Data were collected at 1 months after the Interventions.
Gynecological Cancer Sexual Attitudes
기간: 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).
Data were collected at 3 months after the Interventions.
Sexual Self-Efficacy
기간: Data were collected at baseline
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 baseline
Sexual Self-Efficacy
기간: 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
기간: 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).
Data were collected at 3 months after the Interventions.
Diversity of sexual activity
기간: Data were collected at baseline
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 baseline
Diversity of sexual activity
기간: 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
기간: 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).
Data were collected at 3 months after the Interventions.
Sexual Satisfaction
기간: Data were collected at baseline
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 baseline
Sexual Satisfaction
기간: 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
기간: 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).
Data were collected at 3 months after the Interventions.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 17일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 26일

QC 기준을 충족하는 최초 제출

2026년 8월 26일

처음 게시됨 (실제)

2026년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 112-2629-H-182-001-SS2

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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