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

NCT ID: NCT01335152

Last Updated: 2014-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Coping with Breast Cancer web-based workbook

Intervention Type BEHAVIORAL

10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.

Waitlist control group

Participants will no intervention for the first 10 weeks of the study and then will receive the web-based intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coping with Breast Cancer web-based workbook

10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.

Intervention Type BEHAVIORAL

Other Intervention Names

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Stress management Coping with Cancer Cancer Coping Online workbook

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Talaria, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelly M Carpenter, PhD

Role: PRINCIPAL_INVESTIGATOR

Talaria, Inc

Locations

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Talaria, Inc

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5R44CA106154-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CA106154

Identifier Type: -

Identifier Source: org_study_id

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