Pelvic Health Rehabilitation for Breast and Gynecologic Cancer

(GYVE Trial)

Recruiting at 1 trial location

Overseen By Clémence Bélanger, M.Sc. PT

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to assist individuals who have had breast or gynecologic cancer and face pelvic health issues, such as bladder control problems and pain during sex. These issues can disrupt daily life, and while physiotherapy can help, it is often difficult to access. Participants will engage in a 12-week online program, the Pelvic Health Module, featuring live group sessions led by a physiotherapist. The sessions cover topics like pelvic muscle exercises and pain management. The trial seeks individuals who have had breast or gynecologic cancer in the past three years and are experiencing pelvic health issues. The goal is to determine if this online program can effectively and conveniently improve pelvic health for those affected by cancer. As an unphased trial, this study provides a unique opportunity to access potentially beneficial resources and support for enhancing pelvic health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this eModule is safe for participants?

Research has shown that pelvic health rehabilitation, such as pelvic floor muscle training, is generally safe for cancer survivors. No major safety concerns have been reported, indicating that most individuals can participate without significant issues. This eModule includes exercises and educational sessions to support pelvic health after cancer, led by trained physiotherapists to enhance safety. Studies have not identified any serious problems, making it a promising option for improving quality of life after cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pelvic Health Module because it offers a holistic and proactive approach to pelvic health for breast and gynecologic cancer patients. Unlike traditional treatments that might focus on medication or surgery, this module emphasizes live online group exercises and educational sessions led by a registered physiotherapist. This method not only provides physical rehabilitation but also empowers patients with knowledge, potentially leading to improved long-term pelvic health and quality of life. By offering sessions in both French and English, it also aims to be more inclusive and accessible to a broader patient demographic.

What evidence suggests that this eModule is effective for pelvic health issues in cancer survivors?

Research has shown that pelvic health rehabilitation, such as the Pelvic Health Module tested in this trial, can benefit individuals who have had breast or gynecologic cancer. Studies indicate that many of these individuals, between 40% and 83%, experience urinary incontinence, and up to 100% may face other pelvic issues. This program includes activities like pelvic floor muscle exercises, which can improve these conditions. Early results suggest that such interventions enhance quality of life by reducing symptoms and improving overall pelvic health. The program's online format also increases accessibility, especially for those who have difficulty attending traditional in-person therapy due to cost or availability. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals in Quebec and Edmonton who have undergone treatment for breast or gynecologic cancers and are now facing pelvic health issues such as urinary incontinence, pain during sex, fecal incontinence, constipation, and other related conditions. Participants should be interested in a 12-week online program to improve their pelvic health.

Inclusion Criteria

I am over 18 years old.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants partake in a 12-week online program with weekly group sessions led by a physiotherapist, covering topics like pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management.

12 weeks

12 online group sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention, completing questionnaires to measure impact.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Health Module

Trial Overview The GYVE study tests an online Pelvic Health Module designed to assist cancer survivors with pelvic health problems. It includes weekly group sessions led by physiotherapists covering muscle training, hydration, diet, pain management, and use of vaginal moisturizers over a period of 12 weeks.

How Is the Trial Designed?

Group I: Pelvic Health Module Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

Women who underwent radical hysterectomy reported a significant lack of knowledge about pelvic floor dysfunction (PFD) and rehabilitation options, highlighting the need for improved health education.

Participants expressed a strong desire for multiparty support, including professional and family assistance, to help them cope with PFD and navigate their rehabilitation effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of pelvic floor dysfunction and rehabilitation care amongst women in southeast China after radical hysterectomy: a qualitative study. Lai, YT., Lin, AW., Zheng, ZH., et al.[2022]

In a study of 90 pelvic cancer patients, significant reductions in gastrointestinal (GI), sexual, and urinary symptoms were observed after treatment at a specialized rehabilitation clinic, with GI symptoms decreasing by 36.6%, sexual symptoms by 18.3%, and urinary symptoms by 15.5%.

Patients treated with bile salt sequestrants showed a notable improvement in GI symptoms, particularly diarrhea and fecal incontinence, with 91.3% experiencing a treatment effect, while local estrogens effectively reduced vaginal dryness and pain in 58.1% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late adverse events in patients with pelvic cancer after oncologic treatment-intervention and treatment effect. Iselius, S., Knutsen, A., Mikiver, R., et al.[2023]

A pelvic floor rehabilitation program (PFRP) significantly improved pelvic floor strength and sexual functioning in gynecological cancer survivors, as shown in a study with 34 participants over 4 weeks.

Patients in the PFRP group reported better physical and sexual quality of life compared to those receiving usual health care, indicating the program's effectiveness in enhancing overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pelvic floor muscle training program on gynecologic cancer survivors with pelvic floor dysfunction: a randomized controlled trial. Yang, EJ., Lim, JY., Rah, UW., et al.[2012]

This study aims to explore the preferences and barriers faced by individuals with gynaecological cancer regarding access to virtual pelvic health physiotherapy, which could improve treatment for common issues like vaginal pain and urinary incontinence.

The research will involve 50 participants in Canada through an online survey and virtual focus groups, with the goal of developing a new Pelvic eHealth Module to enhance access to pelvic health services post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences, barriers and facilitators regarding virtual pelvic healthcare in individuals with gynaecological cancers: protocol for a patient-oriented, mixed-methods study. Bernard, S., Tandon, P., Waters, A., et al.[2023]

An in-home rehabilitation program utilizing mobile technology significantly reduced urinary incontinence (UI) severity in 87.5% of endometrial cancer survivors, demonstrating a moderate treatment effect.

The study highlights the potential of mobile technology to improve access to pelvic floor physiotherapy, especially for survivors living in rural and remote areas, addressing a critical gap in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in-home rehabilitation program for the treatment of urinary incontinence symptoms in endometrial cancer survivors: a single-case experimental design study. Bernard, S., McLean, L., Boucher, S., et al.[2022]

In a study of 309 uterine cancer survivors, 76% reported experiencing pelvic floor dysfunction symptoms, but the type of cancer treatment (surgery, brachytherapy, or radiotherapy) did not significantly affect overall pelvic floor dysfunction outcomes.

Factors such as higher body mass index, older age, and more vaginal births were associated with worse urinary-related symptoms, indicating that these personal health factors may play a more critical role in pelvic floor quality of life than the specific treatment received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of treatment modality on pelvic floor dysfunction among uterine cancer survivors. Lakomy, DS., Yoder, AK., Wu, J., et al.[2023]

The pilot study involving 20 women who underwent pelvic radiation therapy found that a psychosexual rehabilitation booklet was perceived as very helpful and informative, enhancing understanding of strategies to manage sexual health post-treatment.

Despite the booklet's positive reception, many women reported that discussions about sexuality were often avoided in clinical settings, indicating a need for improved sexual health communication training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating psychosexual adjustment for women undergoing pelvic radiotherapy: pilot of a novel patient psycho-educational resource. Lubotzky, F., Butow, P., Nattress, K., et al.[2022]

Radiotherapy for gynecological cancers often leads to significant side effects in women, such as vaginal dryness, stenosis, and pain, affecting their sexual health, as analyzed in 19 studies involving 2,739 women.

While there is some evidence suggesting that pelvic floor muscle training (PFMT) may help manage sexual dysfunction after radiotherapy, the current studies are limited in quality and quantity, indicating a need for more rigorous research to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. Barcellini, A., Dominoni, M., Dal Mas, F., et al.[2022]

A study involving 11 women with gynecologic cancer identified key factors that influence adherence to prehabilitation programs aimed at preventing pelvic floor dysfunction, including high self-motivation and support from partners.

Barriers to adherence included general malaise from cancer treatments and discomfort with vaginal dilators, highlighting the need for tailored support and communication from healthcare providers to improve participation in pelvic floor muscle exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to and facilitators of adherence to pelvic floor muscle exercises and vaginal dilator use among gynecologic cancer patients: a qualitative study. Araya-Castro, P., Roa-Alcaino, S., Celedón, C., et al.[2022]

The study found that a psychosexual rehabilitation booklet significantly improved adherence to vaginal dilators and knowledge about post-radiation rehabilitation among 82 women undergoing pelvic radiation therapy for gynaecological or anorectal cancer.

Despite the increased adherence and knowledge, the booklet did not lead to significant improvements in psychological measures like anxiety, depression, or sexual functioning, indicating that while educational resources are helpful, they may not fully address all aspects of post-treatment recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Psychosexual Rehabilitation Booklet Increases Vaginal Dilator Adherence and Knowledge in Women Undergoing Pelvic Radiation Therapy for Gynaecological or Anorectal Cancer: A Randomised Controlled Trial. Lubotzky, FP., Butow, P., Hunt, C., et al.[2020]

Citations

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A pelvic health eRehabilitation program to address ... For people treated for gynecological cancer, the prevalence of urogenital dysfunctions is high: 40%‒83% report urinary incontinence, 40%‒100% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06822582

Pelvic Health Rehabilitation After Breast and Gynecologic ... Outcomes measured will include feasibility (session attendance and study completion), acceptability (participant satisfaction), and effectiveness (changes in ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/575436

Pelvic Health Rehabilitation After Breast and Gynecologic ... The GYVE study aims at testing an online program (eModule) to help people who have had breast or gynecologic cancer and are experiencing ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0330156

A study protocol | PLOS One - Research journals Breast cancer is currently the most diagnosed type of cancer in the world, with a five-year survival rate of 90%. Survivors develop genitourinary dysfunction ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12396660/

A study protocol - PMC - PubMed Central Breast cancer is currently the most diagnosed type of cancer in the world, with a five-year survival rate of 90%.

6. withpower.com withpower.com/trial/phase-gynecologic-cancers-2025-01256

Pelvic Health Rehabilitation for Breast and Gynecologic ... Research on pelvic health rehabilitation, including pelvic floor muscle training, shows it is generally safe for cancer survivors, with no significant safety ...

7. researchgate.net researchgate.net/publication/395795877_A_pelvic_health_eRehabilitation_program_to_address_urogenital_impairments_after_breast_and_gynecologic_cancer_A_proof-of-concept_study_protocol

(PDF) A pelvic health eRehabilitation program to address ... A pelvic health eRehabilitation program to address urogenital impairments after breast and gynecologic cancer: A proof-of-concept study protocol.