Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer

May 7, 2024 updated by: Allison Quick, Ohio State University Comprehensive Cancer Center

Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer

This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.

SECONDARY OBJECTIVE:

I. To preliminarily evaluate the efficacy of a sexual health counseling intervention on patient reported outcomes in quality of life, sexual function, and genitourinary symptoms.

OUTLINE:

Patients receive sexual health counseling prior to starting and at the completion of radiation.

After completion of study, patients are followed up at 1 and 6 months after radiation.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • Any patient with endometrial, cervical, vaginal, or vulvar cancer receiving adjuvant external beam radiation or definitive external beam radiation and brachytherapy will be eligible for the study
  • Those receiving concurrent chemotherapy will be eligible
  • Any prior gynecologic surgery is permitted

Exclusion Criteria:

  • Patients with metastatic or recurrent disease and patients receiving brachytherapy alone

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (sexual health counseling)
Patients receive sexual health counseling prior to starting and at the completion of radiation.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Counseling
Receive sexual health counseling
Other Names:
  • Counseling Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall completion
Time Frame: Up to 6 months post radiation
Patients' characteristics and responses to the questionnaires will be summarized using appropriate summary statistics based on their distributions. Parametric tests such as the student's t test and Chi-square test or nonparametric tests such as Mann-Whitney U test and Fisher's exact test will be used to compare patients' characteristics between patients who completed the program and those who did not.
Up to 6 months post radiation
Individual completion of the counseling sessions and questionnaires
Time Frame: Up to 6 months post radiation
Patients' characteristics and responses to the questionnaires will be summarized using appropriate summary statistics based on their distributions. Parametric tests such as the student's t test and Chi-square test or nonparametric tests such as Mann-Whitney U test and Fisher's exact test will be used to compare patients' characteristics between patients who completed the program and those who did not.
Up to 6 months post radiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: Up to 6 months post radiation
Will be assesses using the European Organization for Research and Treatment of Cancer (EORTC) Core QoL Questionnaire (EORTC QLQ-C30). Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.
Up to 6 months post radiation
Sexual function
Time Frame: Up to 6 months post radiation
Will be assessed using the EORTC QLQ-CX24. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.
Up to 6 months post radiation
Genitourinary symptoms using Vaginal Heal Assessment (VHA)
Time Frame: Up to 6 months post radiation

Will be assessed using the VHA. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.The Vaginal Health Assessment, the examination tool used in the clinical validation of the VAS, will be utilized to for the gynecologic physical examination for all patients. 15 The assessment evaluates the physical aspect of the vagina including agglutination, adhesions, pH, dryness, rugosity, elasticity, length, thickness, epithelial integrity, vascularity, and irritation. Vaginal diameter will also be assessed during the manual portion of the exam.

Estimates will be <2.5, 2.5, 3.0, 3.5, 4.0 or >4 cm. 16
Up to 6 months post radiation
Genitourinary symptoms using Vaginal Assessment Scale (VAS)
Time Frame: Up to 6 months post radiation

Will be assessed using the VAS. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items.

A lower score indicates better function. In cancer patients and survivors, the scale were found to have high internal consistency.
Up to 6 months post radiation

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: Allison M Quick, MD, 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)

May 20, 2021

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-19322
  • NCI-2020-00135 (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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