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

University of British Columbia41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Prospective Surveillance GroupBEHAVIORAL

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.

Education GroupBEHAVIORAL

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 - Shoulder Mobility

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.

Time frame: 12 months

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

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.

Time frame: 12 months

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

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.

Time frame: 12 months

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

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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