Pelvic Health Rehabilitation for Breast and Gynecologic Cancer
(GYVE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Disqualifiers: No internet access, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789How 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.
123610Eligibility Criteria
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
+2 more
Exclusion Criteria
Do not have regular access to internet, to a smart device or a computer, at home.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Pelvic Health ModuleExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
Centre interdisciplinaire de recherche en réadaptation et intégration socialeQuébec, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
References
Barriers to and facilitators of adherence to pelvic floor muscle exercises and vaginal dilator use among gynecologic cancer patients: a qualitative study. [2022]Women with gynecologic cancer may suffer from pelvic floor dysfunction (PFD). Before radiotherapy, prehabilitation with pelvic floor muscle exercises (PFME) and vaginal dilator (VD) might prevent it and foster sexual life. This study aims to explore the experience of gynecologic cancer patients getting external beam radiation treatments regarding barriers to and facilitators of adherence to a prehabilitation program to prevent PFD.
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]Women treated with pelvic radiation therapy (PRT) for gynaecological or anorectal cancer report a high number of sexual problems and unmet post-treatment psychosexual information needs. Currently, there is suboptimal adherence to recommended rehabilitation aids, such as vaginal dilators, and a paucity of resources to facilitate post-radiation rehabilitation and reduce distress in this population. This randomised controlled trial aimed to evaluate the effectiveness of a study-developed psychosexual rehabilitation booklet in this setting.
Perceptions of pelvic floor dysfunction and rehabilitation care amongst women in southeast China after radical hysterectomy: a qualitative study. [2022]To investigate the perceptions of pelvic floor dysfunction (PFD) and rehabilitation care amongst women after radical hysterectomy and to explore ways to improve quality of care.
Facilitating psychosexual adjustment for women undergoing pelvic radiotherapy: pilot of a novel patient psycho-educational resource. [2022]This pilot study aimed to obtain feedback on the feasibility, safety and acceptability of a psychosexual rehabilitation booklet developed for women undergoing pelvic radiation therapy (PRT) and to explore women's sexual, informational and supportive care needs post-PRT rehabilitation.
Preferences, barriers and facilitators regarding virtual pelvic healthcare in individuals with gynaecological cancers: protocol for a patient-oriented, mixed-methods study. [2023]Vaginal pain during intercourse and urinary incontinence are common complaints after gynaecological cancer treatments. Pelvic health physiotherapy treatments aim at optimising function through education on the use of vaginal moisturisers, dilation therapy programme and pelvic floor muscle training. Given that barriers such as time, travel, and costs are known to limit access to physiotherapy services, a virtual pelvic health physiotherapy programme may help to facilitate access. The primary objective of this study is to identify preferences, barriers and facilitators from individuals with gynaecological cancer regarding virtual pelvic healthcare survivorship care.
An in-home rehabilitation program for the treatment of urinary incontinence symptoms in endometrial cancer survivors: a single-case experimental design study. [2022]There is a high prevalence of urinary incontinence among endometrial cancer survivors. They are also known to present with pelvic floor muscle alterations. Evidence on the effects of conservative interventions for the management of UI is scarce. This study aims at verifying the effects of an in-home rehabilitation program, including the use of a mobile technology, to reduce UI severity in endometrial cancer survivors.
Late adverse events in patients with pelvic cancer after oncologic treatment-intervention and treatment effect. [2023]Few studies have focused on the late adverse events after oncologic treatment in pelvic cancer patients. Here, the treatment effect/interventions were studied on late side effects as GI, sexual, and urinary symptoms in pelvic cancer patients who visited a highly specialized rehabilitation clinic in Linköping.
Impact of treatment modality on pelvic floor dysfunction among uterine cancer survivors. [2023]Pelvic floor dysfunction is a common adverse effect of uterine cancer treatment. In this study we compared patient-reported outcomes regarding pelvic floor dysfunction among uterine cancer survivors after hysterectomy and bilateral salpingo-oophorectomy, surgery and brachytherapy, or surgery and external beam radiotherapy with or without brachytherapy versus women who had a hysterectomy for benign indications.
Effect of a pelvic floor muscle training program on gynecologic cancer survivors with pelvic floor dysfunction: a randomized controlled trial. [2012]To investigate the effects of a pelvic floor rehabilitation program (PFRP) on pelvic floor function and quality of life (QoL) in gynecological cancer survivors in a prospective, randomized, controlled trial.
Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. [2022]The present study aims to describe: 1. How the side effects of radiotherapy (RT) could impact sexual health in women; 2. The effectiveness of physical rehabilitation including pelvic floor muscle training (PFMT) in the management of sexual dysfunction after RT.