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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PHQ GAD-7 - Anxiety

Outcome Description:

7-item self-report questionnaire measureing anxiety.

Outcome Time Frame:

baseline, post-intervention, follow-up

Safety Issue:

No

Principal Investigator

Kelly M Carpenter, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Talaria, Inc

Authority:

United States: Institutional Review Board

Study ID:

CA106154

NCT ID:

NCT01335152

Start Date:

April 2010

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • stress
  • depression
  • anxiety
  • web
  • internet
  • coping
  • Breast Neoplasms

Name

Location
Talaria, Inc Seattle, Washington  98122