Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-30

Study Completion Date

2026-12-31

Brief Summary

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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 radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.

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Detailed Description

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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 changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.

III. To compare physical exam and patient-reported outcome trajectories over time.

OUTLINE:

Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.

Conditions

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Anal Carcinoma Cervical Carcinoma Endometrial Carcinoma Malignant Pelvic Neoplasm Rectal Carcinoma Vaginal Carcinoma Vulvar Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Supportive Care (pelvic exam, survey)

Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.

Pelvic Examination

Intervention Type PROCEDURE

Undergo pelvic exam

Survey

Intervention Type OTHER

Complete surveys

Interventions

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Pelvic Examination

Undergo pelvic exam

Intervention Type PROCEDURE

Survey

Complete surveys

Intervention Type OTHER

Other Intervention Names

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internal examination Pelvic Exam Survey Instrument

Eligibility Criteria

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Inclusion Criteria

* 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