Online Stress Management and Coping Skills Training for Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Coping with Breast Cancer web-based workbook
- Registration Number
- NCT01335152
- Lead Sponsor
- Talaria, Inc
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- Cancer diagnosis is a recurrence
- Diagnosis of schizophrenia
- Use of anti-psychotic medication
- Diagnosis of bipolar disorder without use of mood stabilizing medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Web-based workbook Coping with Breast Cancer 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.
- Primary Outcome Measures
Name Time Method PHQ GAD-7 - Anxiety baseline, post-intervention, follow-up 7-item self-report questionnaire measureing anxiety.
CES-D 10 baseline, post-intervention, follow-up 10 item self-report measure of depression.
FACT-B: Functional Assessment of Cancer Therapy - Breast baseline, post-intervention, follow-up 44 item self-report measure of health related quality of life for breast cancer patients.
- Secondary Outcome Measures
Name Time Method Revised Impact of Event Scale baseline, post-intervention, follow-up 22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts.
Benefit Finding Scale for breast cancer baseline, post-intervention, follow-up 17-item self-report measure of finding positive impact of negative events.
CANCER BEHAVIOR INVENTORY (CBI-B) baseline, post-intervention, follow-up 16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.
Trial Locations
- Locations (1)
Talaria, Inc
🇺🇸Seattle, Washington, United States