Alternative Support for Rural and Isolated Women in an HMO

Breast Cancer Clinical Trial

Official title:

Alternative Support for Rural and Isolated Women in an HMO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186212
• Other study ID #: 5BB-1801
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 29, 2011
• Start date: September 2000
• Est. completion date: May 2002

Study information

• Verified date: June 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluate the effects of a workbook/journal for helping isolated women to cope with breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2002
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Depression
• Stress Disorders, Post-traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• workbook/journal on coping with breast cancer

• standard educational materials on breast cancer

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depression
Primary	posttraumatic stress disorder