A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in patient reported anxiety and depression
研究概览
简要总结
This clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-IIIA breast cancer receiving radiation therapy. Beginning radiation therapy for breast cancer can be stressful. Education about what to expect often reduces the stress, anxiety, and depression experienced by these patients. This study is being done to see how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy for patients with breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. Assessment of patient reported anxiety and depression, confidence with information, and side effect expectations of radiation therapy following counseling with or without photo guide at pre-treatment, 2 weeks, 6 months, and 12 months.
SECONDARY OBJECTIVE:
I. Efficacy of intervention to impart reasonable expectations of the side effect burden of radiation therapy (RT).
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients diagnosed with stage 0-IIIA disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment
- •Patients must have the ability to read and understand English
排除标准
- •Patients who are planned for ultra-hypofractionated radiation treatment
- •Patients who are planned for partial breast radiation treatment
- •Patients who are planned to receive concurrent radiosensitizing chemotherapy
研究组 & 干预措施
Arm II (counseling)
Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
干预措施: Questionnaire (Behavioral)
Arm I (counseling, photo guide)
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
干预措施: Counseling (Other)
Arm I (counseling, photo guide)
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
干预措施: Educational Intervention (Other)
Arm I (counseling, photo guide)
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
干预措施: Questionnaire (Behavioral)
Arm II (counseling)
Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
干预措施: Counseling (Other)
结局指标
主要结局
Change in patient reported anxiety and depression
时间窗: Baseline to 12 months
Will use items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (CTCAE). Depression and anxiety will be analyzed as binary outcomes. Will compare questionnaire scores for anxiety and depression between the two groups. Scores will be reported as descriptive using CTCAE grading scale ranging from "mild" (1) to "life threatening" (4).
次要结局
- Cosmesis expectations versus self-reported experiences(Up to 12 months)
研究者
Carl Post
Principal Investigator
OHSU Knight Cancer Institute