Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
Study Details
Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVE:
- To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.
SECONDARY OBJECTIVE:
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supportive Care (sexual health counseling) Patients receive sexual health counseling prior to starting and at the completion of radiation. |
Other: Counseling
Receive sexual health counseling
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Overall completion [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.
- Individual completion of the counseling sessions and questionnaires [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.
Secondary Outcome Measures
- Quality of life (QoL) [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.
- Sexual function [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.
- Genitourinary symptoms using Vaginal Heal Assessment (VHA) [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
- Genitourinary symptoms using Vaginal Assessment Scale (VAS) [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
Investigators
- Principal Investigator: Allison M Quick, MD, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSU-19322
- NCI-2020-00135