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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Overall completion
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.
Time frame: Up to 6 months post radiation
Individual completion of the counseling sessions and questionnaires
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.
Time frame: Up to 6 months post radiation
Quality of life (QoL)
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.
Time frame: Up to 6 months post radiation
Sexual function
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.
Time frame: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Heal Assessment (VHA)
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
Time frame: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Assessment Scale (VAS)
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.
Time frame: Up to 6 months post radiation
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