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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335152
• Other study ID #: CA106154
• Secondary ID: 5R44CA106154-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 12, 2011
• Last updated: May 5, 2014
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2014
• Source: Talaria, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Coping with Breast Cancer web-based workbook
10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.

Locations

Country	Name	City	State
United States	Talaria, Inc	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Talaria, Inc	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ GAD-7 - Anxiety	7-item self-report questionnaire measureing anxiety.	baseline, post-intervention, follow-up	No
Primary	CES-D 10	10 item self-report measure of depression.	baseline, post-intervention, follow-up	No
Primary	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	No
Secondary	Revised Impact of Event Scale	22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts.	baseline, post-intervention, follow-up	No
Secondary	Benefit Finding Scale for breast cancer	17-item self-report measure of finding positive impact of negative events.	baseline, post-intervention, follow-up	No
Secondary	CANCER BEHAVIOR INVENTORY (CBI-B)	16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.	baseline, post-intervention, follow-up	No