Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer
Condition: Lymphedema; Breast Cancer
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

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.
    

Intervention name(s): Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Monitoring