Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Feasibility, as Measured by Session Completion and Attrition
研究概览
简要总结
This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed.
In Phase I of the study, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform the behavioral program development. In Phase II, the program will be refined through user testing interviews (N=12). In Phase III, 88 participants will be randomly assigned to one of two groups:
- One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use.
- The other group will receive written educational materials (enhanced usual care).
The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins.
The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.
详细描述
This study is testing a new behavioral program to help women who have had pelvic radiation therapy use vaginal dilators more regularly. Vaginal dilators are important tools that help prevent or treat vaginal stenosis-a condition where the vagina becomes shorter or narrower after radiation. This can make medical exams and sexual activity painful or difficult. Although dilators are commonly recommended, many women struggle to use them consistently.
The new program is designed to support women in overcoming common challenges to using dilators, such as pain, emotional distress, and lack of information. It includes strategies from cognitive behavioral therapy and acceptance and commitment therapy, and is based on the Health Belief Model, which helps people understand how their beliefs affect their health behaviors.
In Phase I, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform behavioral program development. It is anticipated that the program will employ strategies from cognitive behavioral therapy and acceptance and commitment therapy. In Phase II, the program will be refined through user testing interviews (N=12). In Phase III, 88 participants will be randomly assigned to one of two groups:
- One group will receive the new behavioral program.
- The other group will receive written educational materials (enhanced usual care).
Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months. They will also complete short monthly check-ins to report how often and how long they use their dilators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •female sex
- •adults aged 18 years or older
- •diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and/or bladder
- •completed pelvic radiation therapy in the past year
- •dilator therapy recommended by medical provider and standardized dilator received from provider
- •able to speak/read English
排除标准
- •aged less than 17 years
- •under the care of a pelvic floor physical therapist at the time of study enrollment
- •have a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider
- •inability to provide consent
研究组 & 干预措施
Enhanced Usual Care
Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration).
Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
A 6-session (45 minutes each) behavioral intervention will be delivered individually and remotely via videoconferencing. The intervention will be designed to improve engagement with vaginal dilator therapy among female cancer survivors who underwent pelvic radiation therapy. The intervention includes coping strategies from cognitive behavioral therapy (e.g., progressive muscle relaxation) and acceptance and commitment therapy (e.g., mindfulness), as well as psychoeducation (e.g., how to use dilators), to enhance engagement with vaginal dilator therapy.
干预措施: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation (Behavioral)
结局指标
主要结局
Feasibility, as Measured by Session Completion and Attrition
时间窗: 3 months post-baseline
Feasibility will be determined by 1) greater than or equal to 80% of sessions completed and 2) attrition rate of less than or equal to 20%.
Acceptability, as Measured by the Treatment Acceptability Questionnaire
时间窗: 3 months post-baseline
Acceptability will be determined by average score of 5 or greater on the Treatment Acceptability Questionnaire (TAQ). The TAQ is a six-item measure assessing perceptions of an interventions acceptability, ethics, and effectiveness. Items are rated on a 7-point Likert scale, from "very unacceptable" to "very acceptable".
次要结局
- Change in Dilator Therapy Use(From baseline to end of study enrollment at 9 months)
- Completion of cancer screening(From baseline to end of study enrollment at 9 months)
- Change in symptoms, as measured by the Edmonton Symptom Assessment System(From baseline to end of study enrollment at 9 months)
- Change in depressive symptoms, as measured by the PROMIS Depression Short Form(From baseline to end of study enrollment at 9 months)
- Change in psychological flexibility, as measured by the Acceptance and Action Questionnaire II(From baseline to end of study enrollment at 9 months)
- Change in understanding of psychosocial changes as measured by the modified Knowledge Scale(From baseline to end of study enrollment at 9 months)
- Change in self-efficacy, as measured by the modified Generalized Self-Efficacy Scale(From baseline to end of study enrollment at 9 months)
- Change in perceived susceptibility to developing vaginal stenosis, benefits and barriers to engaging in dilator therapy, as measured by the modified susceptibility, Benefits and Barriers Scale(From baseline to end of study enrollment at 9 months)
- Change in cues that prompt health-promoting behaviors, as measured by the modified Cues to Health Action Questionnaire(From baseline to end of study enrollment at 9 months)
- Change in sexual feelings and responses, as measured by the Female Sexual Function Index(From baseline to end of study enrollment at 9 months)
- Change in anxiety symptoms, as measured by the PROMIS Anxiety Short-Form(From baseline to end of study enrollment at 9 months)