Vaginal Dilator Therapy After Pelvic Radiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation.
- Who it may be relevant to
- Registry conditions: Pelvic Radiotherapy, Vaginal Stenosis, Pelvic Cancer, Gynecologic Cancers. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
Overview
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.
Detailed description
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.
The main goals of the study are to:
* See if the program is easy to use and acceptable to participants. * Track how often participants use their dilators. * Measure changes in symptoms, emotional distress, and knowledge about dilator therapy.
This pilot study will help researchers prepare for a larger study in the future and improve support for women recovering from pelvic radiation.
Interventions
- Behavioral Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
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.
Primary outcome measures
- Feasibility, as Measured by Session Completion and Attrition [Time frame: 3 months post-baseline]
- Acceptability, as Measured by the Treatment Acceptability Questionnaire [Time frame: 3 months post-baseline]
Secondary outcome measures (11)
- Change in Dilator Therapy Use [Time frame: From baseline to end of study enrollment at 9 months]
- Completion of cancer screening [Time frame: From baseline to end of study enrollment at 9 months]
- Change in symptoms, as measured by the Edmonton Symptom Assessment System [Time frame: From baseline to end of study enrollment at 9 months]
- Change in depressive symptoms, as measured by the PROMIS Depression Short Form [Time frame: From baseline to end of study enrollment at 9 months]
- Change in psychological flexibility, as measured by the Acceptance and Action Questionnaire II [Time frame: From baseline to end of study enrollment at 9 months]
- Change in understanding of psychosocial changes as measured by the modified Knowledge Scale [Time frame: From baseline to end of study enrollment at 9 months]
- Change in self-efficacy, as measured by the modified Generalized Self-Efficacy Scale [Time frame: 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 [Time frame: 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 [Time frame: From baseline to end of study enrollment at 9 months]
- Change in sexual feelings and responses, as measured by the Female Sexual Function Index [Time frame: From baseline to end of study enrollment at 9 months]
- Change in anxiety symptoms, as measured by the PROMIS Anxiety Short-Form [Time frame: From baseline to end of study enrollment at 9 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT07216456 · Pro00118002 · 1K08CA304375