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?

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.

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.

Is pelvic health rehabilitation safe for cancer survivors?

Research on pelvic health rehabilitation, including pelvic floor muscle training, shows it is generally safe for cancer survivors, with no significant safety concerns reported in studies involving gynecologic cancer patients. ^{1 2 3 4 5}

How is the Pelvic Health Module treatment different from other treatments for pelvic health issues in cancer patients?

The Pelvic Health Module is unique because it focuses on rehabilitation through pelvic floor muscle exercises and possibly other components, which can help prevent pelvic floor dysfunction and improve sexual health in women undergoing cancer treatment. Unlike standard treatments, it may include prehabilitation strategies to prepare patients before radiotherapy, aiming to enhance adherence and outcomes. ^{1 2 6 7 8}

What data supports the effectiveness of the Pelvic Health Module treatment for pelvic health rehabilitation in breast and gynecologic cancer patients?

Research suggests that pelvic floor muscle exercises and vaginal dilator use can help prevent pelvic floor dysfunction and improve sexual health in women with gynecologic cancer. Additionally, educational resources like psychosexual rehabilitation booklets have been shown to increase adherence to these rehabilitation aids, potentially enhancing their effectiveness. ^{2 6 8 9 10}

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

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. Germany 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. [2022]

2. England 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Perceptions of pelvic floor dysfunction and rehabilitation care amongst women in southeast China after radical hysterectomy: a qualitative study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Facilitating psychosexual adjustment for women undergoing pelvic radiotherapy: pilot of a novel patient psycho-educational resource. [2022]

5. England 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. [2023]

6. England 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Late adverse events in patients with pelvic cancer after oncologic treatment-intervention and treatment effect. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Impact of treatment modality on pelvic floor dysfunction among uterine cancer survivors. [2023]

9. United States 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. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. [2022]