NCT00416780

Brief Summary

RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably. PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable breast-cancer

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

May 30, 2013

Status Verified

March 1, 2006

First QC Date

December 27, 2006

Last Update Submit

May 29, 2013

Conditions

Breast CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentrecurrent breast cancerstage I breast cancerstage II breast cancerstage IV breast cancer

Interventions

counseling interventionOTHER
educational interventionOTHER
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosed with breast cancer * First-time diagnosis of stage I or II disease * No more than 2 months since prior breast cancer surgery * Initial diagnosis of stage IV disease * Distant recurrence of prior breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Reside within a 60-mile radius of the greater Pittsburgh metropolitan area PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CounselingEarly Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Michael Scheier, PhD

    Pittsburgh Mind-Body Center at Carnegie Mellon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Completion

March 1, 2006

Last Updated

May 30, 2013

Record last verified: 2006-03