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Completed

NCT Number: NCT01335152

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Talaria, Inc

Seattle, Washington, 98122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coping with Breast Cancer web-based workbook

Behavioral

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

Primary outcomes

  1. PHQ GAD-7 - Anxiety

    Time frame: baseline, post-intervention, follow-up

    7-item self-report questionnaire measureing anxiety.

  2. CES-D 10

    Time frame: baseline, post-intervention, follow-up

    10 item self-report measure of depression.

  3. FACT-B: Functional Assessment of Cancer Therapy - Breast

    Time frame: baseline, post-intervention, follow-up

    44 item self-report measure of health related quality of life for breast cancer patients.

Secondary outcomes

  1. Revised Impact of Event Scale

    Time frame: baseline, post-intervention, follow-up

    22 item self-report measure of intrusive thoughts and avoidance of cancer-related thoughts.

  2. Benefit Finding Scale for breast cancer

    Time frame: baseline, post-intervention, follow-up

    17-item self-report measure of finding positive impact of negative events.

  3. CANCER BEHAVIOR INVENTORY (CBI-B)

    Time frame: baseline, post-intervention, follow-up

    16-item self-report measure of self-efficacy for coping with cancer and cancer treatment.

Sponsors and collaborators

Lead sponsor

Talaria, Inc

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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