NCT00186212

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

June 29, 2011

Conditions

Stress Disorders, Post-traumaticDepressionBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • depression

  • posttraumatic stress disorder

Interventions

workbook/journal on coping with breast cancerBEHAVIORAL
standard educational materials on breast cancerBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) is a woman; and 2) has been diagnosed with primary breast cancer

You may not qualify if:

  • \) is under 18; or 2) can not speak and read in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionBreast Neoplasms

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cheryl Koopman, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2000

Primary Completion

May 1, 2002

Study Completion

May 1, 2002

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

US(1)