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.
Conditions:
🦠 Dyspareunia 🦠 Pelvic Pain 🦠 Sexual Dysfunction 🦠 Radiation Toxicity
🗓️ Study Start (Actual) 16 January 2024
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Carmel, Indiana, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 September 2023
  • First Submitted that Met QC Criteria 22 September 2023
  • First Posted 28 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2024
  • Last Update Posted 2 May 2024
  • Last Verified May 2024