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

May 5, 2014 updated by: Talaria, Inc

Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98122
        • Talaria, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Stress management
  • Coping with Cancer
  • Cancer Coping
  • Online workbook
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ GAD-7 - Anxiety
Time Frame: baseline, post-intervention, follow-up
7-item self-report questionnaire measureing anxiety.
baseline, post-intervention, follow-up
CES-D 10
Time Frame: baseline, post-intervention, follow-up
10 item self-report measure of depression.
baseline, post-intervention, follow-up
FACT-B: Functional Assessment of Cancer Therapy - Breast
Time Frame: baseline, post-intervention, follow-up
44 item self-report measure of health related quality of life for breast cancer patients.
baseline, post-intervention, follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Impact of Event Scale
Time Frame: baseline, post-intervention, follow-up
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
Time Frame: baseline, post-intervention, follow-up
17-item self-report measure of finding positive impact of negative events.
baseline, post-intervention, follow-up
CANCER BEHAVIOR INVENTORY (CBI-B)
Time Frame: baseline, post-intervention, follow-up
16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.
baseline, post-intervention, follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talaria, Inc

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kelly M Carpenter, PhD, Talaria, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA106154
  • 5R44CA106154-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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