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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA106154-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based workbook | Experimental | 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. |
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| Waitlist control group | No Intervention | Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping with Breast Cancer web-based workbook | Behavioral | 10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly M Carpenter, PhD | Talaria, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Talaria, Inc | Seattle | Washington | 98122 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |