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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Prospective Surveillance Group; Behavioral: Education Group

• Registration Number: NCT02754427
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Results First Submitted: 2018-05-28
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Results First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Surveillance Group	Prospective Surveillance Group	Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.
Education Group	Education Group	Participants in the education group received the usual post-operative follow-up.

Primary Outcome Measures

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