Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prospective Surveillance Group
Education Group
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Surveillance, Physiotherapy, Arm morbidity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prospective Surveillance Group
Education Group
Arm Description
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 in the education group received the usual post-operative follow-up.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02754427
First Posted
April 22, 2016
Last Updated
October 23, 2019
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02754427
Brief Title
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Surveillance, Physiotherapy, Arm morbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective Surveillance Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Group
Arm Type
Active Comparator
Arm Description
Participants in the education group received the usual post-operative follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Prospective Surveillance Group
Other Intervention Name(s)
Prospective surveillance for arm morbidity and physiotherapy treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Group
Other Intervention Name(s)
Attention Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
Description
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
Title
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
Description
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
Title
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
Description
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
Title
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Campbell, PhD
Organizational Affiliation
kristin.campbell@ubc.ca
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
We'll reach out to this number within 24 hrs