Pelvic RadiotherapyNCT07216456
Vaginal Dilator Therapy After Pelvic Radiation
A study testing Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation in people with Pelvic Radiotherapy and Vaginal Stenosis, run by Duke University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Radiotherapy, Vaginal Stenosis, Pelvic Cancer
- What is being tested?
- Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Smrithi Divakaran, MPH, 919-681-7695, smrithi.divakaran@duke.edu
Juliann Stalls, PhD, 919-416-3417, juliann.stalls@duke.edu
About this study
Official title: Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
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:
Read more
- 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.
Read the 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.
- Conditions
- Pelvic Radiotherapy, Vaginal Stenosis, Pelvic Cancer, Gynecologic Cancers, Anorectal Cancer, Urologic Cancer
- Being tested
- Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation
- Keywords
- vaginal dilator therapy, pelvic radiation
- Medical subject headings
- Pelvic Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Engagement with Vaginal Dilator Therapy after Pelvic RadiationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation | Experimental | 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. Receives: Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation |
| Enhanced Usual Care | No intervention | Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 3 months post-baseline
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".
Measured: 3 months post-baseline
Secondary outcomes (11)
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.
Measured: From baseline to end of study enrollment at 9 months
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.
Measured: From baseline to end of study enrollment at 9 months
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.
Measured: From baseline to end of study enrollment at 9 months
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.
Measured: From baseline to end of study enrollment at 9 months
Change in psychological flexibility, as measured by the Acceptance and Action Questionnaire II
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.
Measured: From baseline to end of study enrollment at 9 months
Change in understanding of psychosocial changes as measured by the modified Knowledge Scale
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.
Measured: From baseline to end of study enrollment at 9 months
Change in self-efficacy, as measured by the modified Generalized Self-Efficacy Scale
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.
Measured: 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
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.
Measured: 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
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.
Measured: From baseline to end of study enrollment at 9 months
Change in sexual feelings and responses, as measured by the Female Sexual Function Index
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.
Measured: From baseline to end of study enrollment at 9 months
Change in anxiety symptoms, as measured by the PROMIS Anxiety Short-Form
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.
Measured: From baseline to end of study enrollment at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start5 Mar 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic RadiotherapyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Juliann Stalls, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216456
- Sponsor's protocol ID
- Pro00118002
- Other IDs
- 1K08CA304375
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is our intention to make all data generated from this proposal freely available after it is de-identified. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: qualitative data, patient-reported data from study assessments, and sociodemographic and medical data collected via patient report and health record. Researchers will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07216456
- Acronym / sponsor ID
- Pro00118002
- Conditions
- Pelvic Radiotherapy, Vaginal Stenosis, Pelvic Cancer, Gynecologic Cancers, Anorectal Cancer, Urologic Cancer
- Keywords
- vaginal dilator therapy, pelvic radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation | Experimental | Behavioral: Improving Engagement with Vaginal Dilator Therapy after Pelvic RadiationA 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. |
| Enhanced Usual Care | No intervention | –Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving Engagement with Vaginal Dilator Therapy after Pelvic RadiationThe 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. | Behavioural | Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation |
Primary outcome
Feasibility, as Measured by Session Completion and Attrition
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%.
Acceptability, as Measured by the Treatment Acceptability Questionnaire
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".
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. It is our intention to make all data generated from this proposal freely available after it is de-identified. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: qualitative data, patient-reported data from study assessments, and sociodemographic and medical data collected via patient report and health record. Researchers will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juliann Stalls, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation in people with Pelvic Radiotherapy and Vaginal Stenosis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smrithi Divakaran, MPH (919-681-7695, smrithi.divakaran@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as Measured by Session Completion and Attrition (time frame: 3 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.