Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Talaria, Inc
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PHQ GAD-7 - Anxiety
研究概览
简要总结
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
详细描述
Stress Management interventions have been shown to decrease cancer-related distress, foster emotional growth and improve immune functioning during treatment for breast cancer.
This study will evaluate an online version of a stress management intervention for women with early stage breast cancer. Each chapter of the 10-week intervention include self-assessment and targeted feedback, education, interactive learning exercises -- all tailored to the needs of women with early stage breast cancer. In addition, guided writing exercises will promote emotional expression and a discussion board will encourage group support.
The web-based intervention is being evaluated in a randomized clinical trial with a sample of 120 women with early stage breast cancer. Women will be randomly assigned to use the 10-week intervention with biweekly telephone assessments or to the telephone assessments alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosis of stage 0, I, II or III breast cancer within past 18 months
- •Elevated stress, distress or negative mood
- •Access at least 1.5 - 2 hours per week to a computer with audio capabilities that is connected to the internet
- •Ability to read, write, and speak English at a sixth grade level
- •Access to a telephone and an active e-mail account
排除标准
- •Cancer diagnosis is a recurrence
- •Diagnosis of schizophrenia
- •Use of anti-psychotic medication
- •Diagnosis of bipolar disorder without use of mood stabilizing medication
研究组 & 干预措施
Web-based workbook
Participants will use one chapter of the web-based workbook each week for 10 weeks. The workbook consists of stress management education, cognitive behavioral interventions and relaxation training exercises.
干预措施: Coping with Breast Cancer web-based workbook (Behavioral)
Waitlist control group
Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention.
结局指标
主要结局
PHQ GAD-7 - Anxiety
时间窗: baseline, post-intervention, follow-up
7-item self-report questionnaire measureing anxiety.
CES-D 10
时间窗: baseline, post-intervention, follow-up
10 item self-report measure of depression.
FACT-B: Functional Assessment of Cancer Therapy - Breast
时间窗: baseline, post-intervention, follow-up
44 item self-report measure of health related quality of life for breast cancer patients.
次要结局
- Revised Impact of Event Scale(baseline, post-intervention, follow-up)
- Benefit Finding Scale for breast cancer(baseline, post-intervention, follow-up)
- CANCER BEHAVIOR INVENTORY (CBI-B)(baseline, post-intervention, follow-up)