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

NCT01335152 | Completed Phase 1 DMC

• 2 other identifiers: CA1061545R44CA106154-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stress; depression; anxiety; web; internet; coping

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Coping with Breast Cancer web-based workbook

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.

Interventions

Coping with Breast Cancer web-based workbook BEHAVIORAL

10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.

Also known as: Stress management, Coping with Cancer, Cancer Coping, Online workbook

Web-based workbook

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cancer diagnosis is a recurrence
• Diagnosis of schizophrenia
• Use of anti-psychotic medication
• Diagnosis of bipolar disorder without use of mood stabilizing medication

Sponsors & Collaborators

• Talaria, Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Talaria, Inc

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kelly M Carpenter, PhD

  Talaria, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

US (1)