Clinical trial NCT04713618: Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
Official title: Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anal Carcinoma
Cervical Carcinoma
Endometrial Carcinoma
Malignant Pelvic Neoplasm
Rectal Carcinoma
Vaginal Carcinoma
Vulvar Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with gynecologic and colorectal cancers who are receiving either external beam radiation or brachytherapy from The Ohio State University James Cancer Hospital Radiation Oncology clinic

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.

Eligibility criteria: 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

Exclusion Criteria:

* Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
* Patients who have received prior pelvic radiation

Primary outcomes:
measure: Change in physical exam findings
timeFrame: Baseline up to 2 years after radiation therapy (RT)
measure: Change in vulvovaginal symptoms
timeFrame: Baseline up to 2 year after RT
measure: Change in sexual function
timeFrame: Baseline up to 2 year after RT
Secondary outcomes:
measure: Change in vaginal microbiome
timeFrame: Baseline up to 2 year after RT
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Elizabeth K Arthur, PhD
role: PRINCIPAL_INVESTIGATOR
References: