Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Individual completion of the counseling sessions and questionnaires
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with metastatic or recurrent disease and patients receiving brachytherapy alone
结局指标
主要结局
Individual completion of the counseling sessions and questionnaires
时间窗: 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.
Overall completion
时间窗: 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.
次要结局
- Quality of life (QoL)(Up to 6 months post radiation)
- Genitourinary symptoms using Vaginal Heal Assessment (VHA)(Up to 6 months post radiation)
- Genitourinary symptoms using Vaginal Assessment Scale (VAS)(Up to 6 months post radiation)
- Sexual function(Up to 6 months post radiation)
研究者
Allison Quick
Principal Investigator
Ohio State University Comprehensive Cancer Center