Status:
ACTIVE_NOT_RECRUITING
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Anal Carcinoma
Cervical Carcinoma
Eligibility:
FEMALE
18+ years
Brief Summary
This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiati...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer. II. To examine chan...
Eligibility Criteria
Inclusion
- Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy
- Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166
- Any prior gynecologic surgery is permitted
- Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
Exclusion
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Patients who have received prior pelvic radiation
Key Trial Info
Start Date :
January 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04713618
Start Date
January 30 2021
End Date
December 31 2026
Last Update
March 18 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210