Pelvic Health Rehabilitation After Breast and Gynecologic Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Pelvic Health Module

    Behavioral

    Telerehabilitation program involving pelvic floor exercises, education and counselling.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pelvic Health ModuleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

1

Adherence Rate

number of intervention sessions attended/participant

Time frame
From enrollment to the end of intervention at 12 weeks
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.