NCT00268502

Brief Summary

RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

December 20, 2005

Last Update Submit

November 12, 2015

Conditions

Breast CancerCancer SurvivorDepressionFatigueSexual DysfunctionSleep DisordersSpiritual Concerns

Keywords

fatiguedepressionspiritual concernssexual dysfunctionsleep disorderscancer survivorstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Interventions

study of socioeconomic and demographic variablesOTHER
fatigue assessment and managementPROCEDURE
management of therapy complicationsPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * African-American or Caucasian breast cancer survivor * Diagnosed with stage I-III breast cancer between the years of 1995-2003 * Receiving follow up care at the Indiana University Cancer Center (IUCC), the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital * Healthy African-American * Acquaintance of an African-American breast cancer survivor * Not known to have breast cancer PATIENT CHARACTERISTICS: * Female 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

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsDepressionFatigueSexual Dysfunction, PhysiologicalSleep Wake Disorders

Interventions

TherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital DiseasesNervous System DiseasesNeurologic ManifestationsMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kathleen Russell, RN, DNS

    Indiana University Melvin and Bren Simon Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

December 1, 2005

Primary Completion

November 1, 2007

Study Completion

April 1, 2014

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

US(1)