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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Talaria, Inc
ClinicalTrials.gov Identifier:
NCT01335152
First received: April 12, 2011
Last updated: May 5, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Talaria, Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: April 2010
Study Completion Date: August 2011
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:
  • 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.

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335152

Locations
United States, Washington
Talaria, Inc
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Talaria, Inc
Investigators
Principal Investigator: Kelly M Carpenter, PhD Talaria, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Talaria, Inc
ClinicalTrials.gov Identifier: NCT01335152     History of Changes
Other Study ID Numbers: CA106154, 5R44CA106154-03
Study First Received: April 12, 2011
Last Updated: May 5, 2014
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 July 22, 2014