Recruiting

Pelvic Health Rehabilitation

Sponsor:

Laval University

Code:

NCT06822582

Conditions

Gynecologic Cancers

Breast Cancer Female

Incontinence

Incontinence Bowel

Sexual Dysfunction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic Health Module

Study Details

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.

Conditions

Gynecologic Cancers

Breast Cancer Female

Incontinence

Incontinence Bowel

Sexual Dysfunction

Study ID

NCT06822582

Start date

Jan 7, 2025

Status verified date

Feb, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Pelvic Health Module

Telerehabilitation program involving pelvic floor exercises, education and counselling.

Primary outcome measure

  • Perceived effectiveness of the intervention [ Time Frame: From enrollment to the end of intervention at 12 weeks ]

Central Contacts and Locations

Central contacts

Stéphanie Bernard, Ph.D. PT

418-529-9141stephanie.bernard@fmed.ulaval.ca

Clémence Bélanger, M.Sc. PT

418-529-9141labo.rpponco@gmail.com

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2G4

Contacts

Margaret McNeely, Ph.D. PT

780-492-6007mmcneely@ualberta.ca

Chris Sellar

780-492-6007frmace@ualberta.ca

Principal Investigator:

Margaret McNeely

Centre interdisciplinaire de recherche en réadaptation et intégration sociale

Recruiting

Québec, Quebec, Canada, G1M2S8

Contacts

Clémence Bélanger, M.Sc. PT

418-529-9141labo.rpponco@gmail.com

Principal Investigator:

Stéphanie Bernard

More Information

Sponsor

Laval University

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Keywords

  • pelvic health
  • telerehabilitation
  • supportive cancer care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-02-12.