Online Stress Management and Coping Skills Training for Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Coping with Breast Cancer web-based workbook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cancer diagnosis is a recurrence Diagnosis of schizophrenia Use of anti-psychotic medication Diagnosis of bipolar disorder without use of mood stabilizing medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based workbook<br>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. | Behavioral: Coping with Breast Cancer web-based workbook<br>* 10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.<br>* Other names: Online workbook;|
| No Intervention: Waitlist control group<br>Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ GAD-7 - Anxiety | 7-item self-report questionnaire measureing anxiety. | baseline, post-intervention, follow-up | 
| CES-D 10 | 10 item self-report measure of depression. | baseline, post-intervention, follow-up | 
| FACT-B: Functional Assessment of Cancer Therapy - Breast | 44 item self-report measure of health related quality of life for breast cancer patients. | baseline, post-intervention, follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Impact of Event Scale | 22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts. | baseline, post-intervention, follow-up | 
| Benefit Finding Scale for breast cancer | 17-item self-report measure of finding positive impact of negative events. | baseline, post-intervention, follow-up | 
| CANCER BEHAVIOR INVENTORY (CBI-B) | 16-item self-report measure of self-efficacy for coping with cancer and cancer treatment. | baseline, post-intervention, follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, depression, anxiety, web, internet, coping