NCT02752659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

April 18, 2016

Last Update Submit

March 9, 2018

Conditions

LymphedemaBreast Cancer

Keywords

Monitoring

Outcome Measures

Primary Outcomes (3)

  • 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.

    Self-measures performed twice with 2 days apart

  • 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.

    Both measures are performed same day within one hour

  • 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.

    Both measures are performed same day within one hour

Study Arms (2)

Women with breast cancer-related lymphedema

EXPERIMENTAL

Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.

Procedure: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference

Women at risk of breast cancer-related lymphedema

EXPERIMENTAL

Participants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer.

Procedure: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference

Interventions

Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumferencePROCEDURE
Women at risk of breast cancer-related lymphedemaWomen with breast cancer-related lymphedema

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30289500DERIVED

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 27, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

CA(1)