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

• ClinicalTrials.gov Identifier: NCT04713618
• Recruitment Status: Recruiting
• First Posted: January 19, 2021
• Last Update Posted: December 3, 2021
• Sponsor: Ohio State University Comprehensive Cancer Center
• Information provided by (Responsible Party): Elizabeth Arthur, Ohio State University Comprehensive Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment
Anal Carcinoma; Cervical Carcinoma; Endometrial Carcinoma; Malignant Pelvic Neoplasm; Rectal Carcinoma; Vaginal Carcinoma; Vulvar Carcinoma	Procedure: Pelvic Examination; Other: Survey

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 Design

• Study Type: Observational
• Estimated Enrollment: 89 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
• Actual Study Start Date: January 30, 2021
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2023

Groups and Cohorts

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 Name: Survey Instrument

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• 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

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

Contacts and Locations

Contacts

Contact: The Ohio State University Comprehensive Cancer Center; 800-293-5066; OSUCCCClinicaltrials@osumc.edu

Locations

United States, Ohio

Ohio State University Comprehensive Cancer Center; Recruiting

Columbus, Ohio, United States, 43210

Contact: Elizabeth Arthur, PhD, APRN-CPN 614-293-0811 Liz.arthur@osumc.edu

Principal Investigator: Elizabeth Arthur, PhD, APRN-CPN

Sub-Investigator: Allison Quick, MD

Sub-Investigator: Andrea Arnett, MD PhD

Sub-Investigator: Erin Healy, MD

Principal Investigator: Daniel Spakowicz, PhD

Sub-Investigator: Xiaokui Mo, PhD

Sub-Investigator: Eric Miller, MD

Sub-Investigator: Alexandra Diaz-Pardo, MD

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Elizabeth K Arthur, PhD, APRN-CPN; Ohio State University Comprehensive Cancer Center

More Information

Additional Information:

The Jamesline 

• Responsible Party: Elizabeth Arthur, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT04713618
• Other Study ID Numbers: OSU-19342; NCI-2020-04790 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: January 19, 2021
• Last Update Posted: December 3, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma; Endometrial Neoplasms; Anus Neoplasms; Vulvar Neoplasms; Pelvic Neoplasms; Vaginal Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Vulvar Diseases; Vaginal Diseases