RECRUITING

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Conditions

Dyspareunia Pelvic Pain Sexual Dysfunction Radiation Toxicity vaginal dilator pelvic health physical therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Quick Facts

Study Start:2024-01-16

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06059586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	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

Inclusion Criteria

Exclusion 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
* 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

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

Contacts and Locations

Study Contact

Namita Agrawal, MD

CONTACT

(317)944-2524

agrawaln@indiana.edu

Sarah Dutkevich, RN

CONTACT

(317)278-5618

sdutkevi@iu.edu

Principal Investigator

Namita Agrawal, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

IU Health Schwarz Cancer Center

Carmel, Indiana, 46032

United States

Collaborators and Investigators

Sponsor: Indiana University

Namita Agrawal, MD, PRINCIPAL_INVESTIGATOR, Indiana University

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

Study Start Date2024-01-16

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

vaginal dilator
pelvic health physical therapy

Additional Relevant MeSH Terms

Dyspareunia
Pelvic Pain
Sexual Dysfunction
Radiation Toxicity