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

Talaria

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Behavioral: Coping with Breast Cancer web-based workbook

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01335152

5R44CA106154-03 (U.S. NIH Grant/Contract)

CA106154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Web-based workbook

Experimental group

Description:

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.

Treatment:

Behavioral: Coping with Breast Cancer web-based workbook

Waitlist control group

No Intervention group

Description:

Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention.