NCT00336089

Brief Summary

RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors. PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

September 17, 2013

Status Verified

July 1, 2009

Enrollment Period

2.9 years

First QC Date

June 8, 2006

Last Update Submit

September 16, 2013

Conditions

Breast CancerCancer SurvivorFatiguePain

Keywords

fatiguepaincancer survivorbreast cancer in situinflammatory breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancer

Interventions

exercise interventionBEHAVIORAL
educational interventionOTHER
complementary or alternative medicine procedurePROCEDURE
fatigue assessment and managementPROCEDURE
management of therapy complicationsPROCEDURE
pain therapyPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Breast cancer survivor * Received adjuvant chemotherapy or radiotherapy for breast cancer only * Must have completed treatment 2-6 months ago * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Hemoglobin ≥ 11 g/dL * Able to read English * No high-risk for cardiovascular problems during exercise, including any of the following: * Unstable heart disease * Unstable angina * Chronic respiratory disease * Dizziness * Uncontrolled hypertension * No severe respiratory disease requiring oxygen therapy * No history of anorexia (body mass index \[BMI\] \< 18.5) or severe obesity (BMI \> 35) * No history of multiple cancers * No shortness of breath or hypotension * No sudden swelling of the ankles, hands or face * No palpitations or arrhythmias * No persistent and intolerable pain * No major acute illness (e.g., fever or respiratory infection) 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 (2)

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

RECRUITING

Clayton State University

Morrow, Georgia, 30260-0285, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsFatiguePainBreast Carcinoma In SituInflammatory Breast Neoplasms

Interventions

Early Intervention, EducationalTherapeuticsAnalgesia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesAnesthesia and Analgesia

Study Officials

  • Melanie Poudevigne, PhD

    Clayton State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Last Updated

September 17, 2013

Record last verified: 2009-07

Locations

US(2)