Pelvic Health Rehabilitation After Breast and Gynecologic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

NCT06059586

Dyspareunia Pelvic Pain Sexual Dysfunction +1 more

RECRUITING NA

An Individualized Online Home-Based Exercise Program for Improving Symptoms in Gynecologic Cancer Survivors

NCT06709534

Malignant Female Reproductive System Neoplasm

RECRUITING NA

Study of Physical and Psychosocial Rehabilitation Needs of Patients After Diagnosis and Treatment of Upper Gastrointestinal Cancer or Gynecological Cancer

NCT01216813

Adenocarcinoma of the Gastroesophageal Junction Cervical Cancer Endometrial Cancer +7 more

COMPLETED

Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study

NCT03935698

Gynecological Cancer Dyspareunia

COMPLETED NA

Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors

NCT06331403

Colorectal Cancer Anal Cancer Sexual Dysfunction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Cancers Breast Cancer Female Incontinence Incontinence Bowel Sexual Dysfunction Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot interventional prospective cohort design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Pelvic Health Module

Intervention Type BEHAVIORAL

Telerehabilitation program involving pelvic floor exercises, education and counselling.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pelvic Health Module

Telerehabilitation program involving pelvic floor exercises, education and counselling.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.