Duke University Medical Center
Durham, North Carolina, 27710, United States
Location status: Recruiting
Location contact
Juliann Stalls, PhD
CONTACT
Juliann Stalls, PhD
PRINCIPAL_INVESTIGATOR
Smrithi Divakaran, MPH
CONTACT
NCT Number: NCT07216456
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Juliann Stalls, PhD
CONTACT
Juliann Stalls, PhD
PRINCIPAL_INVESTIGATOR
Smrithi Divakaran, MPH
CONTACT
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:
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:
This pilot study will help researchers prepare for a larger study in the future and improve support for women recovering from pelvic radiation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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%.
Time frame: 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".
Time frame: From baseline to end of study enrollment at 9 months
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.
Time frame: From baseline to end of study enrollment at 9 months
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.
Time frame: From baseline to end of study enrollment at 9 months
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.
Time frame: From baseline to end of study enrollment at 9 months
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.
Time frame: From baseline to end of study enrollment at 9 months
The Acceptance and Action Questionnaire II (AAQ-II) is a 7-item measure of psychological flexibility. Participants are asked to rate items on a 7-point scale from "1" (never true) to "7" (always true) and item scores are summed to create a total score between 7 and 49. Higher scores indicate lower psychological flexibility. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
A 14-item modified version of a Knowledge Scale developed by previous researchers will be used to assess understanding of psychosexual changes following pelvic radiation therapy and use and purpose of vaginal dilator therapy and other rehabilitation strategies. Higher summed scores on the knowledge scale indicate greater knowledge. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
The Generalized Self-Efficacy Scale is a 10-item measure of self-efficacy. Respondents are asked to rate individuals items on a 4 point scale from "1" (not at all true) to "4" (exactly true). Items on this measure will be modified to assess self-efficacy with engaging in dilator therapy. Scores will be summed for a total between 10 and 40. Higher summed scores indicate greater self-efficacy to engage in dilator therapy. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
The 19-item Revised Susceptibility, Benefits, and Barriers Scale for mammography screening will be modified to assess perceived susceptibility to developing vaginal stenosis, benefits to engaging in dilator therapy, and barriers to engaging in dilator therapy. Items are rated on a 5-point Likert-type scale from "1" (strongly agree) to "5" (strongly disagree). Higher subscale scores indicate a lower degree of perceived susceptibility, benefits, and barriers, respectively. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
The Cues to Health Action Questionnaire is a 32-item measure assessing cues that prompt health-promoting behaviors. The specific target action that will be emphasized in measure instructions is engaging in dilator therapy. Respondents will be asked to rank order specific cues to action for engaging dilator therapy. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
The Female Sexual Function Index (FSFI) is a 19-item measure assessing sexual feelings and responses over the past 4 weeks. Participants are asked to rate individual items on a 5 or 6 point Likert-type scales, ranging from "0" or "1" to "5", with higher total score indicating greater sexual functioning. This will be assessed every 3 months by self-report.
Time frame: From baseline to end of study enrollment at 9 months
The PROMIS Anxiety Short Form will be used to assess anxiety symptoms. This is an 7-item measure assessing symptoms of anxiety experienced over the last week. Participants will be asked to respond to items using a five-point scale ranging from "1" (never) to "5" (always). Responses will be summed for a total score between 7 and 35, with higher scores indicating higher levels of anxiety symptoms. This will be assessed every 3 months by self-report.
Contact information is provided by the study sponsor or research team.
Duke University
Other
Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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