Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT04713618
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 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.
Study:
NCT04713618
Study Brief:
Protocol Section:
NCT04713618