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.
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
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
Parallel
Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
BehavioralThe 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.
Feasibility, as Measured by Session Completion and Attrition
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
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".
Change in Dilator Therapy Use
Dilator therapy use will be assessed monthly via text survey by four items used in prior research to assess average frequency of dilator use, average duration of dilator use per dilation, frequency of penetrative sexual activity, and frequency of alternate dilator use over the past month.
Completion of cancer screening
Completion of cancer screening/surveillance that involved a pelvic exam will be assessed by asking one item about the frequency of completing recommended pelvic exams for cancer screening/surveillance in the past three months. This will be assessed every 3 months via self-report.
Change in symptoms, as measured by the Edmonton Symptom Assessment System
The Edmonton Symptom Assessment System is a 10-item self-report scale of 9 common symptoms experienced by cancer patients. There is a 10th item in which patients can write in and rate another specific symptom experienced. Participants are asked to rate individual symptom burden on an 11 point scale (0-10) with higher scores indicating greater symptom burden. This will be assessed every 3 months by self-report.
Change in depressive symptoms, as measured by the PROMIS Depression Short Form
Depressive symptoms will be assessed using the PROMIS Depression Short Form. This is an 8-item measure assessing symptoms of depression experienced over the last week. Participants will be asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from "1" (never) to "5" (always). This will be assessed every 3 months by self-report.
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Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
