An interventional study of Pelvic Health Module in Gynecologic Cancers, Breast Cancer Female and Incontinence, sponsored by Laval University. Recruiting at 2 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
The GYVE study aims at testing an online program (eModule) to help people who have had breast or gynecologic cancer and are experiencing pelvic health issues like urinary incontinence and pain during sex. These cancers and their treatments can cause significant pelvic health problems, affecting daily life and quality of life. Physiotherapy can help, but access is often limited due to costs and other barriers. The study will involve 20 participants from Quebec and Edmonton, who will take part in a 12-week program with weekly online group sessions led by a physiotherapist. Topics include pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management. Led by experts in cancer rehabilitation and pelvic health, the study aims to provide valuable information on the feasibility and effectiveness of the eModule, potentially leading to broader implementation to help more people with lived experience of cancer.
The GYVE study aims at testing a new online program (eModule) designed to help people who have had breast or gynecologic cancer and are experiencing pelvic health issues such as urinary incontinence and pain during sex. These cancers are common and can cause pelvic health problems due to treatments like surgery, radiation, and hormone therapy. Many people treated for these cancers experience issues that affect their daily lives and quality of life. Physiotherapy for pelvic health can help, but access to these services is often limited due to costs, travel, and other barriers. The study's goals are to see if the new eModule is practical and well-received by participants and to check if it helps reduce pelvic health problems. More specifically, this study aims to:
Obj 1) Evaluate the feasibility and the acceptability of implementing the new eModule, as perceived by people treated for breast or gynecological cancer.
Obj 2) Explore the preliminary effectiveness of the new eModule in reducing urogenital impairments.
The hypothesis is that the eModule will be practical and well-liked, with at least 70% of participants completing the study and over 85% reporting high satisfaction. The study will be conducted in Quebec and Edmonton with 20 participants who have had breast or gynecologic cancer and are experiencing pelvic health issues. The eModule will last 12 weeks and include weekly online group sessions led by a physiotherapist, covering topics like pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management. Participants will complete questionnaires before, during, and after the program to measure its impact. Outcomes measured will include feasibility (session attendance and study completion), acceptability (participant satisfaction), and effectiveness (changes in pelvic health issues). The study will follow ethical guidelines to protect participants' privacy and ensure their informed consent.
The study is led by experts in cancer rehabilitation and pelvic health from various Canadian institutions and will take place over several months, with phases for preparation, recruitment, intervention, data collection, and analysis. If successful, this study will provide valuable information on the feasibility and effectiveness of the eModule, potentially leading to larger studies and broader implementation to help more people with lived experience of cancer.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 20 is below the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
Compared within Dyspareunia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sexual Dysfunction, Physiological. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants from the experimental (single) arm will partake in a 12-week intervention involving weekly live online group exercises and educational sessions in French or English. The sessions will be led and supervised by a registered physiotherapist with expertise in pelvic health.
Behavioral: Pelvic Health Module
Telerehabilitation program involving pelvic floor exercises, education and counselling.
Perceived effectiveness of the intervention
The Patient Global Impression of Change scale will be used to determine the extent to which the intervention is perceived as likely to remedy urogenital deficiencies.
Time frame: From enrollment to the end of intervention at 12 weeks
Adherence Rate
number of intervention sessions attended/participant
Time frame: From enrollment to the end of intervention at 12 weeks
Attrition rate
number of participants who did not complete participation / those who did.
Time frame: From enrollment to the end of intervention at 12 weeks
International Consultation on Incontinence Questionnaire
a modular questionnaire for urinary symptoms (12 items) and bowel symptoms (20 items).
Time frame: From enrollment to the end of intervention at 12 weeks
Vulvar Pain Assessment Questionnaire
a 38-item questionnaire to assess vulvar pain intensity
Time frame: From enrollment to the end of intervention at 12 weeks
Female Sexual Function Index
a 19-item multidimensional questionnaire to assess six domains of sexual functioning: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Time frame: From enrollment to the end of intervention at 12 weeks
Perceived Self-Efficacy scale
modified from the self-efficacy for chronic disease management questionnaire, a 6-item survey to determine a person's perceived overall ability to cope with symptoms in various challenging or stressful situations.
Time frame: From enrollment to the end of intervention at 12 weeks
Program's acceptability
questions developed in connection with program acceptability (Relevance of content, Perceived burden, Appropriateness of intervention and sense of safety, Usability, Geographical accessibility, Satisfaction with ease of access to intervention, Previous access to services, Barriers, and Perceived best time in cancer care trajectory)
Time frame: From enrollment to the end of intervention at 12 weeks
Plan to share: Undecided
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