Intelligent Sexual Health Information Support System for Gynecological Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-70
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of other malignant tumors.
Intellectual disability or mental disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Intelligent Sexual Health Information Support with Proactive Nurse Researcher Contact
Other interventionThe 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.
Intelligent Sexual Health Information Support with Safety-Triggered Nurse Researcher Contact
Other interventionThe 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.
Usual Gynecologic Cancer Care
Other interventionThe 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: The experimental group A -Proactive Nurse Support GroupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention
Group C: The experimental group B -Alert-Triggered Nurse Support GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Women Sexual Distress
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.
Time frame
Data were collected at baseline2
The Women Sexual Distress
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.
Time frame
Data were collected at 1 months after the Interventions.3
The Women Sexual Distress
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.
Time frame
Data were collected at 3 months after the Interventions.4
Gynecological Cancer Sexual Knowledge
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).
Time frame
Data were collected at baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chang Gung Memorial Hospital
Lead sponsor
National Science and Technology Council, Taiwan
Collaborator
Source ClinicalTrials.gov