Breast Cancer
Conditions
Keywords
stress, depression, anxiety, web, internet, coping
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.
Interventions
BEHAVIORALCoping with Breast Cancer web-based workbook
10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.
Sponsors
National Cancer Institute (NCI)
Talaria, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed