Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
October 23, 2019 updated by: Kristin Campbell, University of British Columbia
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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:
|
|
Active Comparator: Education Group
Participants in the education group received the usual post-operative follow-up.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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.
|
12 months
|
|
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.
|
12 months
|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristin Campbell, PhD, kristin.campbell@ubc.ca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 22, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Actual)
October 25, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-01773
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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