NCT00851812

Brief Summary

The purpose of this study is to examine if exercise helps improve cancer-related fatigue. Hypothesis: A structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

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

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

12.7 years

First QC Date

February 24, 2009

Last Update Submit

February 13, 2020

Conditions

Fatigue

Keywords

ExerciseBreast cancerfatigue

Outcome Measures

Primary Outcomes (1)

  • Cancer-related fatigue

    4.5 months

Secondary Outcomes (1)

  • To provide preliminary data on influence of QOL and it's relationship to CRF

    4.5 months

Study Arms (2)

Arm 1

OTHER

Usual Care: Standard care monitoring

Behavioral: Exercise

Arm 2

EXPERIMENTAL

Progressive walking and resistance exercise treatment

Behavioral: Progressive walking and resistance exercise treatment

Interventions

ExerciseBEHAVIORAL

Standard care monitoring

Also known as: Usual care: standard care monitoring
Arm 1
Progressive walking and resistance exercise treatmentBEHAVIORAL

Home-based exercise : Progressive walking and resistance program

Arm 2

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a primary diagnosis of breast cancer,
  • Have a functional capacity rating of 60 or greater on the Karnofsky Performance Scale, when assessed by the oncologist (or physician's designee)
  • Be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). Have a life expectancy of \>1 year as determined by the patient's oncologist.
  • Have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program.
  • Be able to read English.
  • Be 21 years of age or older.
  • Give informed consent.

You may not qualify if:

  • Have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis.
  • Have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the PAR-Q and radiation oncologist (or physician's designee)
  • Be identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James P. Wilmot Cancer Center, University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

FatigueMotor ActivityBreast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karen Mustian, Ph.D.

    James P. Wilmot Cancer Center, University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 26, 2009

Study Start

May 1, 2007

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

US(1)