Back to resultsAlternative Support for Rural and Isolated Women in an HMO
Primary Purpose
Stress Disorders, Post-traumatic, Depression, Breast Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
workbook/journal on coping with breast cancer
standard educational materials on breast cancer
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-traumatic
Eligibility Criteria
Inclusion Criteria: 1) is a woman; and 2) has been diagnosed with primary breast cancer Exclusion Criteria: 1) is under 18; or 2) can not speak and read in English
Sites / Locations
- Stanford University
Outcomes
Primary Outcome Measures
depression
posttraumatic stress disorder
Secondary Outcome Measures
Full Information
NCT ID
NCT00186212
First Posted
September 13, 2005
Last Updated
June 29, 2011
Sponsor
Stanford University
Collaborators
University of California, Berkeley
1. Study Identification
Unique Protocol Identification Number
NCT00186212
Brief Title
Alternative Support for Rural and Isolated Women in an HMO
Official Title
Alternative Support for Rural and Isolated Women in an HMO
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
May 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
University of California, Berkeley
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the effects of a workbook/journal for helping isolated women to cope with breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-traumatic, Depression, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
workbook/journal on coping with breast cancer
Intervention Type
Behavioral
Intervention Name(s)
standard educational materials on breast cancer
Primary Outcome Measure Information:
Title
depression
Title
posttraumatic stress disorder
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) is a woman; and 2) has been diagnosed with primary breast cancer
Exclusion Criteria:
1) is under 18; or 2) can not speak and read in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Koopman, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Alternative Support for Rural and Isolated Women in an HMO
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