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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective Surveillance Group

Behavioral

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.

Other names: Prospective surveillance for arm morbidity and physiotherapy treatment

Education group

Behavioral

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.

Other names: Attention Control Group

Primary outcomes

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 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 - 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.
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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 28, 2016
Registry last updated: Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed