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临床试验/NCT06822582
NCT06822582招募中不适用

A Pelvic Health EModule to Address Urogenital Impairments After Breast and Gynecologic Cancer: a Pilot Prospective Interventional Study

Laval University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Perceived effectiveness of the intervention

研究概览

简要总结

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.

详细描述

The GYVE study aims at testing a new online program (eModule) designed to help people who have had breast or gynecologic cancer and are experiencing pelvic health issues such as urinary incontinence and pain during sex. These cancers are common and can cause pelvic health problems due to treatments like surgery, radiation, and hormone therapy. Many people treated for these cancers experience issues that affect their daily lives and quality of life. Physiotherapy for pelvic health can help, but access to these services is often limited due to costs, travel, and other barriers. The study's goals are to see if the new eModule is practical and well-received by participants and to check if it helps reduce pelvic health problems. More specifically, this study aims to:

Obj 1) Evaluate the feasibility and the acceptability of implementing the new eModule, as perceived by people treated for breast or gynecological cancer.

Obj 2) Explore the preliminary effectiveness of the new eModule in reducing urogenital impairments.

The hypothesis is that the eModule will be practical and well-liked, with at least 70% of participants completing the study and over 85% reporting high satisfaction. The study will be conducted in Quebec and Edmonton with 20 participants who have had breast or gynecologic cancer and are experiencing pelvic health issues. The eModule will last 12 weeks and include weekly online group sessions led by a physiotherapist, covering topics like pelvic floor muscle training, use of vaginal moisturizers, hydration, diet, and pain management. Participants will complete questionnaires before, during, and after the program to measure its impact. Outcomes measured will include feasibility (session attendance and study completion), acceptability (participant satisfaction), and effectiveness (changes in pelvic health issues). The study will follow ethical guidelines to protect participants' privacy and ensure their informed consent.

The study is led by experts in cancer rehabilitation and pelvic health from various Canadian institutions and will take place over several months, with phases for preparation, recruitment, intervention, data collection, and analysis. If successful, this study will provide valuable information on the feasibility and effectiveness of the eModule, potentially leading to larger studies and broader implementation to help more people with lived experience of cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Pelvic Health Module (Behavioral)

结局指标

主要结局

Perceived effectiveness of the intervention

时间窗: From enrollment to the end of intervention at 12 weeks

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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