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

March 6, 2024 updated by: Elizabeth Arthur, Ohio State University Comprehensive Cancer Center

Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Pelvic Examination
Undergo pelvic exam
Other Names:
  • internal examination
  • Pelvic Exam
Other: Survey
Complete surveys
Other Names:
  • Survey Instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical exam findings
Time Frame: Baseline up to 2 years after radiation therapy (RT)
Vaginal Health Assessment (VHA) tool; vaginal length and diameter will be reported as categorical variables (Eaton et al., 2017). Estimates will be <2.5, 2.5, 3.0, 3.5, 4.0 or >4 cm. Vaginal length will be estimated based on manual exam. Estimates will be <4cm, 4-6cm, and >6cm. We will first test bivariate correlations between physical exam outcomes and categorical sociodemographic factors using Fisher's exact test at each time point. The study team will test bivariate correlations between physical exam outcomes and continuous sociodemographic factors using ANOVA at each time point. Next, the study team will employ one-tailed Wilcoxon signed-rank test to assess the effects of radiation by comparing 1-month, 3-month, 6-month, 12-month and 24-month physical exam outcomes to baseline.
Baseline up to 2 years after radiation therapy (RT)
Change in vulvovaginal symptoms
Time Frame: Baseline up to 2 year after RT
The Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS) are tools to identify vulvovaginal symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia. Items are scored 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Baseline up to 2 year after RT
Change in sexual function
Time Frame: Baseline up to 2 year after RT
Female Sexual Functioning Index (FSFI) is a 19 item self -reported instrument measuring six domains of sexual functioning including arousal, orgasm, satisfaction and pain. The maximum score is 36 and a score of ≤ 26.0 indicates sexual dysfunction. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Baseline up to 2 year after RT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaginal microbiome
Time Frame: Baseline up to 2 year after RT
The Lactobacillus to Prevotella ratio (LPR) will be calculated. The vaginal dryness (binary, VAS score <=2 vs >2) will be related to the LPR (continuous) by logistic regression. A significant relationship of LPR with vaginal dryness will be evaluated by Wald test. The LPR is correlated with abundance of macrophages by Spearman correlation. Spearman correlation is used to determine the association between LPR relative abundance and expression of a gene or composition of the immune cells. We will use linear discriminant analysis to explore a linear combination of gene expression, microbe relative abundance and immune cell composition to predict vaginal dryness. The level of inflammation in the tissue will be estimated by aggregating the expression of standard "inflammasome" genes. LPR will be correlated with the aggregated inflammation value by Spearman correlation.
Baseline up to 2 year after RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Elizabeth K Arthur, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2021

Primary Completion (Actual)

October 1, 2023

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-19342
  • NCI-2020-04790 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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