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Clinical Trials/NCT02754427
NCT02754427
Completed
Not Applicable

Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer

University of British Columbia0 sites41 target enrollmentFebruary 2013
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of British Columbia
Enrollment
41
Primary Endpoint
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
August 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristin Campbell

Associate Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.

Exclusion Criteria

  • prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema

Outcomes

Primary Outcomes

Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength

Time Frame: 12 months

Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms.

Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume

Time Frame: 12 months

Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer.

Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility

Time Frame: 12 months

Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.

Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function

Time Frame: 12 months

Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.

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