Intelligent Sexual Health Information Support System for Gynecological Cancer Patients
9 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
90
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jian Tao LEE, Professor
- Numero di telefono: 5197 886-03-2118800
- Email: jtlee@gap.cgu.edu.tw
Luoghi di studio
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Guishan
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Taoyuan, Guishan, Taiwan, 333
- Reclutamento
- Cheng Gung Memorial Hospital
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Contatto:
- Jian Tao LEE, Professor
- Numero di telefono: 5197 886-03-2118800
- Email: jtlee@gap.cgu.edu.tw
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Women Sexual Distress
Lasso di tempo: 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.
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Data were collected at baseline
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The Women Sexual Distress
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Gynecological Cancer Sexual Knowledge
Lasso di tempo: 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).
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Data were collected at baseline
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Gynecological Cancer Sexual Knowledge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Sexual Self-Efficacy
Lasso di tempo: 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).
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Data were collected at baseline
|
|
Sexual Self-Efficacy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Guntupalli SR, Sheeder J, Ioffe Y, Tergas A, Wright JD, Davidson SA, Behbakht K, Flink DM. Sexual and Marital Dysfunction in Women With Gynecologic Cancer. Int J Gynecol Cancer. 2017 Mar;27(3):603-607. doi: 10.1097/IGC.0000000000000906.
- Goodman RS, Patrinely JR, Stone CA Jr, Zimmerman E, Donald RR, Chang SS, Berkowitz ST, Finn AP, Jahangir E, Scoville EA, Reese TS, Friedman DL, Bastarache JA, van der Heijden YF, Wright JJ, Ye F, Carter N, Alexander MR, Choe JH, Chastain CA, Zic JA, Horst SN, Turker I, Agarwal R, Osmundson E, Idrees K, Kiernan CM, Padmanabhan C, Bailey CE, Schlegel CE, Chambless LB, Gibson MK, Osterman TJ, Wheless LE, Johnson DB. Accuracy and Reliability of Chatbot Responses to Physician Questions. JAMA Netw Open. 2023 Oct 2;6(10):e2336483. doi: 10.1001/jamanetworkopen.2023.36483.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 giugno 2026
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 dicembre 2026
Date di iscrizione allo studio
Primo inviato
26 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 agosto 2026
Primo Inserito (Effettivo)
31 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 settembre 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 112-2629-H-182-001-SS2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .