Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
Primary Purpose
Lymphedema, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference
Sponsored by
About this trial
This is an interventional other trial for Lymphedema focused on measuring Monitoring
Eligibility Criteria
Inclusion Criteria:
- women, who have received surgery for breast cancer with axillary or sentinel lymph node dissection within the last 3 months to 5 years, including those who are undergoing chemotherapy or radiation
- with and without a clinical diagnosis of BCRL in one or two arms
- age 18 to 80 years
- who can understand the self-measurement instructions given in English
- who have access and ability to use internet to view the self-measurement video tutorial
Exclusion Criteria:
-
Sites / Locations
- University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Women with breast cancer-related lymphedema
Women at risk of breast cancer-related lymphedema
Arm Description
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
Outcomes
Primary Outcome Measures
Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference
ICC is scored from 0 to 1. Reliability is considered poor when the ICC < 0.40, moderate between 0.40 and 0.75, substantial between 0.75 and 0.90, and excellent when >0.90. The total agreement between self-measured arm circumference performed twice by the participant will be calculated.
Intra-class correlation coefficients (ICC) for inter-rater reliability between arm circumference measures performed by the participant herself and by the therapist.
The total agreement between self-measured arm circumference performed by the participant and by a physiotherapist will be calculated.
Intra-class correlation coefficients (ICC) for concurrent validity of self-measured arm circumference and perometer-measures
The total agreement between self-measured arm circumference performed by the participant and by a perometer will be calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT02752659
First Posted
April 18, 2016
Last Updated
March 9, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02752659
Brief Title
Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
Official Title
Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
June 2017 (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
Early detection and treatment of onset or worsening of breast cancer-related lymphedema (BCRL) can potentially prevent or postpone the condition to progress into a chronic progressive condition or eliminate the risk of infections in the arm (cellulitis). Self-surveillance for BCRL by routinely measuring own arm circumference could potentially enable early detection of onset or worsening of lymphedema. The aim is to determine whether women who have received surgery for breast cancer, can perform self-measures of arm circumference in a reliable and valid manner using written and video supported instructions without in-person teaching by a physiotherapist.
Detailed Description
Purpose: to test the reliability and validity of self-measured arm circumference compared to measures performed by a specialized therapist and by the perometer (gold standard).
The hypothesis is that there will be an excellent correlation between arm circumference measures performed by the participant and by an experienced physiotherapist and a moderate correlation between arm circumference measures performed by the patient and determined by perometer, as well as arm volume calculated from arm circumference measurements and measured by the perometer.
Design: A cross-sectional study of women at risk of breast cancer-related lymphedema (BCRL) (n=20) and with BCRL (n=20)
Procedures: Participants will complete one self-assessment at home and one self-assessment at a laboratory the University of British Columbia (UBC).
Home Self-assessment: Participants will be sent a study package by mail, which will contain the consent form, a tape measure, written instructions supplemented with illustrations, a link for a video guide, and a measurement form, along with an opaque envelop for the measurement form. Participants will be asked to first review the written and video material outlining the measurement process, prior to completing a short self-assessment quiz on the self-measurement technique. Participants will then perform arm circumference measures of both arms as per the instructions, record the measurements on the provided form and seal the form in a provided envelope. The envelope will be returned to the study team at the lab assessment.
Lab Self-assessment: At the visit at UBC, participants will be asked by study staff to repeat these arm circumference measures with support from the video and written instructions, unsupervised by a physiotherapist. This will be followed by an assessment by the physiotherapist and measures with the perometer.
Statistical analysis plan: Intra-rater (between self-measures performed at home and at the lab), inter-rater reliability (between self-measures performed at lab and therapist-measures) and concurrent validity analysis (between self-measures performed at lab and perometer measures) will be conducted separately for women with and without BCRL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Breast Cancer
Keywords
Monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women with breast cancer-related lymphedema
Arm Type
Experimental
Arm Description
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
Arm Title
Women at risk of breast cancer-related lymphedema
Arm Type
Experimental
Arm Description
Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.
Intervention Type
Procedure
Intervention Name(s)
Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference
Primary Outcome Measure Information:
Title
Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference
Description
ICC is scored from 0 to 1. Reliability is considered poor when the ICC < 0.40, moderate between 0.40 and 0.75, substantial between 0.75 and 0.90, and excellent when >0.90. The total agreement between self-measured arm circumference performed twice by the participant will be calculated.
Time Frame
Self-measures performed twice with 2 days apart
Title
Intra-class correlation coefficients (ICC) for inter-rater reliability between arm circumference measures performed by the participant herself and by the therapist.
Description
The total agreement between self-measured arm circumference performed by the participant and by a physiotherapist will be calculated.
Time Frame
Both measures are performed same day within one hour
Title
Intra-class correlation coefficients (ICC) for concurrent validity of self-measured arm circumference and perometer-measures
Description
The total agreement between self-measured arm circumference performed by the participant and by a perometer will be calculated.
Time Frame
Both measures are performed same day within one hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women, who have received surgery for breast cancer with axillary or sentinel lymph node dissection within the last 3 months to 5 years, including those who are undergoing chemotherapy or radiation
with and without a clinical diagnosis of BCRL in one or two arms
age 18 to 80 years
who can understand the self-measurement instructions given in English
who have access and ability to use internet to view the self-measurement video tutorial
Exclusion Criteria:
-
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30289500
Citation
Rafn BS, McNeely ML, Camp PG, Midtgaard J, Campbell KL. Self-Measured Arm Circumference in Women With Breast Cancer Is Reliable and Valid. Phys Ther. 2019 Feb 1;99(2):240-253. doi: 10.1093/ptj/pzy117.
Results Reference
derived
Learn more about this trial
Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
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