Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

NCT06059586 | Recruiting DMC

• 1 other identifier: CTO-IUSCCC-0772
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sexual Dysfunction; Radiation Toxicity; Dyspareunia; Pelvic Pain

Keywords

vaginal dilator; pelvic health physical therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Average score on the Visual Pain Rating Scale.

  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

  Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation

• Percentage of adherence to dilator use

  Immediately upon radiation completion, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation

Study Arms (1)

Pelvic health Assessment and Intervention

EXPERIMENTAL

Behavioral: Pelvic health therapy; Device: Dilator feasability

Interventions

Pelvic health therapy BEHAVIORAL

Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education

Pelvic health Assessment and Intervention

Dilator feasability DEVICE

Patient Adherence to Vaginal Dilation Questionnaire

Pelvic health Assessment and Intervention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

IU Health West

Avon, Indiana, 46123, United States

RECRUITING

IU Health Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Dyspareunia; Pelvic Pain; Sexual Dysfunction, Physiological; Radiation Injuries

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Namita Agrawal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Namita Agrawal, MD

CONTACT

(317)944-2524; agrawaln@indiana.edu

Sarah Dutkevich, RN

CONTACT

(317)278-5618; sdutkevi@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (3)