search
Back to results

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
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Surveillance, Physiotherapy, Arm morbidity

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 22, 2016
    Last Updated
    October 23, 2019
    Sponsor
    University of British Columbia
    search

    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