Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.

Detailed Description
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Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles. The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?

Official Title
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Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Conditions
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Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity

Intervention / Treatment
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* Behavioral: Pelvic health therapy
* Device: Dilator feasability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female ≥ 18 years old at the time of informed consent Ability to provide written informed consent and HIPAA authorization Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion Notes: Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center Exclusion Criteria: Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up. Not a candidate for curative radiation therapy per radiation oncologist's discretion Prior radiation therapy to the pelvis Women who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic health Assessment and Intervention<br> | Behavioral: Pelvic health therapy<br>* Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education<br>Device: Dilator feasability<br>* Patient Adherence to Vaginal Dilation Questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasability of implementation of pre-rehabilitation to radiotherapy | Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented. | Baseline | 
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of eligible patients that were not identified for protocol enrollment will be recorded and potential gaps in the screening process will be analyzed. | Baseline | 
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded. | Baseline | 
| Feasability of implementation of pre-rehabilitation to radiotherapy | The duration of time from initial clinical presentation to being offered information of clinical study will be recorded. | Baseline | 
| Feasability of implementation of pre-rehabilitation to radiotherapy | The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded. | Baseline to 6 weeks | 
| Feasability of implementation of pre-rehabilitation to radiotherapy | The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded. | Baseline to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average score on the Visual Pain Rating Scale. | Visual Analogue Pain Rating Scale 0-10 | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | 
| Evaluate female sexual function based on questionnaire responses | Female Sexual Function Index questionnaires (Likert scale) | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | 
| Percentage of adherence to dilator use | Self-reported dilator adherence | Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal dilator, pelvic health physical therapy