Intelligent Sexual Health Information Support System for Gynecological Cancer Patients
9 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jian Tao LEE, Professor
- Número de teléfono: 5197 886-03-2118800
- Correo electrónico: jtlee@gap.cgu.edu.tw
Ubicaciones de estudio
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Guishan
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Taoyuan, Guishan, Taiwán, 333
- Reclutamiento
- Cheng Gung Memorial Hospital
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Contacto:
- Jian Tao LEE, Professor
- Número de teléfono: 5197 886-03-2118800
- Correo electrónico: jtlee@gap.cgu.edu.tw
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Women Sexual Distress
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Gynecological Cancer Sexual Attitudes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
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Diversity of sexual activity
Periodo de tiempo: 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.
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Sexual Satisfaction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
31 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 112-2629-H-182-001-SS2
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .