Clinical trial NCT06822582: Pelvic Health Rehabilitation After Breast and Gynecologic Cancer
Official title: A Pelvic Health eModule to Address Urogenital Impairments After Breast and Gynecologic Cancer: a Pilot Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancers
Breast Cancer Female
Incontinence
Incontinence Bowel
Sexual Dysfunction
Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia
Constipation
Keywords: pelvic health
telerehabilitation
supportive cancer care
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot interventional prospective cohort design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* be \>18 years of age;
* have received a diagnosis of breast or gynecological (endometrial, cervical, ovarian, vulvar or vaginal) cancer (Stage I-IV) ;
* be on active cancer treatment or have completed any cancer treatment (surgery and/or radiation therapy and/or chemotherapy) within the last 3 years;
* be able to provide informed written consent in English or French;
* have a urogenital dysfunction, as screened by a score of ≥ 2 on the Pelvic Floor Bother Questionnaire.

Exclusion Criteria:

* do not have regular access to internet, to a smart device or a computer, at home.

Primary outcomes:
measure: Perceived effectiveness of the intervention
timeFrame: From enrollment to the end of intervention at 12 weeks
Secondary outcomes:
Other outcomes:
measure: Adherence Rate
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Attrition rate
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: International Consultation on Incontinence Questionnaire
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Vulvar Pain Assessment Questionnaire
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Female Sexual Function Index
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Perceived Self-Efficacy scale
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Program's acceptability
timeFrame: From enrollment to the end of intervention at 12 weeks
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Québec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et intégration sociale
state: Quebec
Study officials:
References: