Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
N
Namita Agrawal
Primary Investigator
Enrolling By Invitation
18 years and older
Female
Phase
N/A
20 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Behavioral: Pelvic health therapy
- Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
- Patient Adherence to Vaginal Dilation Questionnaire
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity
-
Age: 18 Years
-
Gender: Female
Inclusion Criteria:
- 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 Criteria:
- 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
Updated on
01 Aug 2024.
Study ID: CTO-IUSCCC-0772, 19190
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