LymphedemaNCT02752659
Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
A study testing Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference in people with Lymphedema and Breast Cancer, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
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.
Read the 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.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference
- Keywords
- Monitoring
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumferenceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Both measures are performed same day within one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Campbell, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752659
- Sponsor's protocol ID
- H16-00961
- Status last verified
- Mar 2018
- First submitted
- 18 Apr 2016
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30289500
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02752659
- Acronym / sponsor ID
- H16-00961
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer-related lymphedema | Experimental | Procedure: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumferenceParticipants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer. |
| Women at risk of breast cancer-related lymphedema | Experimental | Procedure: Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumferenceParticipants will measure their own arm circumference and be measured by a specialized physiotherapist and by a perometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference | Procedure or surgery | Women at risk of breast cancer-related lymphedema, Women with breast cancer-related lymphedema |
Primary outcome
Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference
Time frame: Self-measures performed twice with 2 days apart
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.
Time frame: Both measures are performed same day within one hour
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
Time frame: Both measures are performed same day within one hour
The total agreement between self-measured arm circumference performed by the participant and by a perometer will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Derived from this study: PubMed 30289500Rafn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference in people with Lymphedema and Breast Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-class correlation coefficients (ICC) for intra-rater reliability of self-measured arm circumference (time frame: Self-measures performed twice with 2 days apart). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.