RecruitingNot ApplicableNCT06059586

Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy

Sponsor

Indiana University

Enrollment

20 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

Sexual Dysfunction Radiation Toxicity Dyspareunia Pelvic Pain

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria4

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

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Interventions

BEHAVIORALPelvic health therapy

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

DEVICEDilator feasability

Patient Adherence to Vaginal Dilation Questionnaire