Clinical trial NCT01335152: Online Stress Management and Coping Skills Training for Women With Breast Cancer
Official title: Coping With Breast Cancer and Treatment: An E-Learning Course for Skills and Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: stress
depression
anxiety
web
internet
coping
Lead sponsor: Talaria, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-04-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: PHQ GAD-7 - Anxiety
timeFrame: baseline, post-intervention, follow-up
measure: CES-D 10
timeFrame: baseline, post-intervention, follow-up
measure: FACT-B: Functional Assessment of Cancer Therapy - Breast
timeFrame: baseline, post-intervention, follow-up
Secondary outcomes:
measure: Revised Impact of Event Scale
timeFrame: baseline, post-intervention, follow-up
measure: Benefit Finding Scale for breast cancer
timeFrame: baseline, post-intervention, follow-up
measure: CANCER BEHAVIOR INVENTORY (CBI-B)
timeFrame: baseline, post-intervention, follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Talaria, Inc
state: Washington
Study officials:
affiliation: Talaria, Inc
name: Kelly M Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References: