NCT06822582

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 7, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

January 29, 2025

Last Update Submit

February 11, 2025

Conditions

Gynecologic CancersBreast Cancer FemaleIncontinenceIncontinence BowelSexual DysfunctionVaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, DyspareuniaConstipation

Keywords

pelvic healthtelerehabilitationsupportive cancer care

Outcome Measures

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.

    From enrollment to the end of intervention at 12 weeks

Other Outcomes (7)

  • Adherence Rate

    From enrollment to the end of intervention at 12 weeks

  • Attrition rate

    From enrollment to the end of intervention at 12 weeks

  • International Consultation on Incontinence Questionnaire

    From enrollment to the end of intervention at 12 weeks

  • +4 more other outcomes

Study Arms (1)

Pelvic Health Module

EXPERIMENTAL

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

Interventions

Pelvic Health ModuleBEHAVIORAL

Telerehabilitation program involving pelvic floor exercises, education and counselling.

Pelvic Health Module

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G2G4, Canada

RECRUITING

Centre interdisciplinaire de recherche en réadaptation et intégration sociale

Québec, Quebec, G1M2S8, Canada

RECRUITING

MeSH Terms

Conditions

EncopresisSexual Dysfunction, PhysiologicalDyspareuniaConstipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersGenital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, Psychological

Central Study Contacts

Stéphanie Bernard, Ph.D. PT

CONTACT

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

Clémence Bélanger, M.Sc. PT

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot interventional prospective cohort design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 12, 2025

Study Start

January 7, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

CA(2)