Intelligent Sexual Health Information Support System for Gynecological Cancer Patients
9 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Status
Recrutamento
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Intervencional
Inscrição (Estimado)
Inscrição
90
Estágio
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
Contato de estudo
- Nome: Jian Tao LEE, Professor
- Número de telefone: 5197 886-03-2118800
- E-mail: jtlee@gap.cgu.edu.tw
Locais de estudo
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Guishan
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Taoyuan, Guishan, Taiwan, 333
- Recrutamento
- Cheng Gung Memorial Hospital
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Contato:
- Jian Tao LEE, Professor
- Número de telefone: 5197 886-03-2118800
- E-mail: jtlee@gap.cgu.edu.tw
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
3
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
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Comparador Ativo: 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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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Women Sexual Distress
Prazo: 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
Prazo: 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.
|
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The Women Sexual Distress
Prazo: 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
Prazo: 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
Prazo: 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.
|
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Gynecological Cancer Sexual Knowledge
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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Diversity of sexual activity
Prazo: 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).
|
Data were collected at baseline
|
|
Diversity of sexual activity
Prazo: 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
Prazo: 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
Prazo: 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).
|
Data were collected at baseline
|
|
Sexual Satisfaction
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
17 de junho de 2026
Conclusão Primária (Estimado)
Conclusão Primária
1 de dezembro de 2026
Conclusão do estudo (Estimado)
Conclusão do estudo
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de agosto de 2026
Primeira postagem (Real)
Primeira postagem
31 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
11 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- 112-2629-H-182-001-SS2
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .