Malignant Female Reproductive System Neoplasm Clinical Trial
Official title:
Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer
| Verified date | May 2024 |
| Source | Ohio State University Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | April 6, 2023 |
| Est. primary completion date | April 6, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 6 months post radiation | |
| Primary | 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. | Up to 6 months post radiation | |
| Secondary | 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. | Up to 6 months post radiation | |
| Secondary | 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. | Up to 6 months post radiation | |
| Secondary | 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 |
Up to 6 months post radiation | |
| Secondary | 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. |
Up to 6 months post radiation |
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