Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction; Pelvic Pain; Radiation Toxicity; Dyspareunia
• Intervention / Treatment: Behavioral: Pelvic health therapy; Device: Dilator feasability

Detailed Description

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?

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Namita Agrawal, MD; Phone Number: (317)944-2524; Email: agrawaln@indiana.edu
• Study Contact Backup: Name: Sarah Dutkevich, RN; Phone Number: (317)278-5618; Email: sdutkevi@iu.edu

Study Locations

• United States
  • Indiana
    • Avon, Indiana, United States, 46123
      • Recruiting
      • IU Health West
      • Contact: Nikki Barrow; Phone Number: 317-944-1242; Email: nrbarrow@iu.edu
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • IU Health Schwarz Cancer Center
      • Contact: John Spittler; Phone Number: 3172740771; Email: ajspittl@iu.edu
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Contact: Sarah Dutkevitch, RN; Phone Number: 317-278-5618; Email: sdutkevi@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female
2. ≥ 18 years old at the time of informed consent
3. Ability to provide written informed consent and HIPAA authorization
4. Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
5. 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:

1. 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.
2. Not a candidate for curative radiation therapy per radiation oncologist's discretion
3. Prior radiation therapy to the pelvis
4. Women who are pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Namita Agrawal, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: vaginal dilator; pelvic health physical therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Mental Disorders; Wounds and Injuries; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunctions, Psychological; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pelvic Pain; Dyspareunia; Sexual Dysfunction, Physiological; Radiation Injuries
• Other Study ID Numbers: CTO-IUSCCC-0772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No