Online Stress Management and Coping Skills Training for Women With Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Behavioral: Coping with Breast Cancer web-based workbook |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies |
- PHQ GAD-7 - Anxiety [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]7-item self-report questionnaire measureing anxiety.
- CES-D 10 [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]10 item self-report measure of depression.
- FACT-B: Functional Assessment of Cancer Therapy - Breast [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]44 item self-report measure of health related quality of life for breast cancer patients.
- Revised Impact of Event Scale [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts.
- Benefit Finding Scale for breast cancer [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]17-item self-report measure of finding positive impact of negative events.
- CANCER BEHAVIOR INVENTORY (CBI-B) [ Time Frame: baseline, post-intervention, follow-up ] [ Designated as safety issue: No ]16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: Coping with Breast Cancer web-based workbook
10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.
Other Names:
|
|
No Intervention: Waitlist control group
Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Kelly Carpenter, PhD, Senior Research Scientist, Talaria, Inc |
| ClinicalTrials.gov Identifier: | NCT01335152 History of Changes |
| Other Study ID Numbers: | CA106154, 5R44CA106154-03 |
| Study First Received: | April 12, 2011 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Talaria, Inc:
|
stress depression anxiety |
web internet coping |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013