Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Talaria, Inc
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- PHQ GAD-7 - Anxiety
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
PHQ GAD-7 - Anxiety
Time Frame: baseline, post-intervention, follow-up
7-item self-report questionnaire measureing anxiety.
CES-D 10
Time Frame: baseline, post-intervention, follow-up
10 item self-report measure of depression.
FACT-B: Functional Assessment of Cancer Therapy - Breast
Time Frame: baseline, post-intervention, follow-up
44 item self-report measure of health related quality of life for breast cancer patients.
Secondary Outcomes
- 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)