Trials / Active Not Recruiting
Active Not RecruitingNCT04713618
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (estimated)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
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 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
- Anal Carcinoma
- Cervical Carcinoma
- Endometrial Carcinoma
- Malignant Pelvic Neoplasm
- Rectal Carcinoma
- Vaginal Carcinoma
- Vulvar Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pelvic Examination | Undergo pelvic exam |
| OTHER | Survey | Complete surveys |
Timeline
- Start date
- 2021-01-30
- Primary completion
- 2023-10-01
- Completion
- 2026-12-31
- First posted
- 2021-01-19
- Last updated
- 2025-03-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04713618. Inclusion in this directory is not an endorsement.