Alternative Support for Rural and Isolated Women in an HMO | NCT00186212

Studies
Alternative Support for Rural and Isolated Women in an HMO

NCT00186212

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jul 1, 2011Estimated

Enrollment

150Actual

Phase

Phase 3

Conditions

Stress Disorders, Post-traumatic
Depression
Breast Cancer

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

May 2002Actual

Completion Date

May 2002Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2011

Last Update Posted Date

Jul 1, 2011Estimated

Name	Class
University of California, Berkeley	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
workbook/journal on coping with breast cancer	Behavioral
standard educational materials on breast cancer	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cheryl Koopman, Ph.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D003863	Depression
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
depression
posttraumatic stress disorder