Pelvic Health Rehabilitation After Breast and Gynecologic Cancer (GYVE)

February 11, 2025 updated by: Laval University

A Pelvic Health EModule to Address Urogenital Impairments After Breast and Gynecologic Cancer: a Pilot Prospective Interventional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2G4
        • Recruiting
        • University of Alberta
        • Contact:
        • Contact:
        • Contact:
          • Margaret McNeely
    • Quebec
      • Québec, Quebec, Canada, G1M2S8
        • Recruiting
        • Centre interdisciplinaire de recherche en réadaptation et intégration sociale
        • Contact:
        • Contact:
          • Stéphanie Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic Health Module
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived effectiveness of the intervention
Time Frame: From enrollment to the end of intervention at 12 weeks
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.
From enrollment to the end of intervention at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Rate
Time Frame: From enrollment to the end of intervention at 12 weeks
number of intervention sessions attended/participant
From enrollment to the end of intervention at 12 weeks
Attrition rate
Time Frame: From enrollment to the end of intervention at 12 weeks
number of participants who did not complete participation / those who did.
From enrollment to the end of intervention at 12 weeks
International Consultation on Incontinence Questionnaire
Time Frame: From enrollment to the end of intervention at 12 weeks
a modular questionnaire for urinary symptoms (12 items) and bowel symptoms (20 items).
From enrollment to the end of intervention at 12 weeks
Vulvar Pain Assessment Questionnaire
Time Frame: From enrollment to the end of intervention at 12 weeks
a 38-item questionnaire to assess vulvar pain intensity
From enrollment to the end of intervention at 12 weeks
Female Sexual Function Index
Time Frame: From enrollment to the end of intervention at 12 weeks
a 19-item multidimensional questionnaire to assess six domains of sexual functioning: desire, arousal, lubrication, orgasm, satisfaction, and pain.
From enrollment to the end of intervention at 12 weeks
Perceived Self-Efficacy scale
Time Frame: From enrollment to the end of intervention at 12 weeks
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.
From enrollment to the end of intervention at 12 weeks
Program's acceptability
Time Frame: From enrollment to the end of intervention at 12 weeks
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)
From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-13-2025-3199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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