The study was designed to use prospective, repeated measures on 211 female participants newly-diagnosed with breast cancer. Participant recruitment and data collection took place at a Midwestern university-affiliated state cancer centre. Consent was obtained and the participants were then enrolled. They were assessed pre-and post-treatment, every three months for 12 months, then every six months thereafter, for a total of 30 months.
Two objective measurement techniques were used at each visit to quantify limb volume characteristics: circumferential measurement and infra-red perometery. Traditional anthropometric measurements recorded limb girth every 4cm on each arm using a non-stretch, flexible tape measure. Infra-red perometry (Perometer 400T/350S, Juzo, Cuyahoga Falls, OH) was used to record three-dimensional images of each limb, which were used to calculate limb volume. A detailed description of these techniques has been previously published (Armer and Stewart, 2005 ).
In addition to the two objective measures, one subjective analysis of LE symptoms was administered each visit through the LE and Breast Cancer Questionnaire (LBCQ) (Armer et al, 2003 (link)). The LBCQ, which has previously been validated, consists of 57 questions examining 19 signs and symptoms drawn from the literature and clinical observation (Armer et al, 2003 (link)). Based on these previous findings, self-report of heaviness or swelling ‘now’ or ‘in the past year’, was included as one definition for LE.
From those measurements, four criteria for identifying LE were used:
Certain participants met the definitions for LE before treatment at the baseline (pre-treatment) measurement for one or more of the four criteria used. Those participants were included in the study, but not for analysis in that particular criteria, resulting in different numbers of participants for a given criteria. For example, 16 of the 211 participants met the definition for LE at baseline based on the criteria of self-reported limb heaviness and swelling, resulting in 195 participants in the subsequent self-report analysis. Also, those participants who had both right and left limbs affected due to bilateral mastectomies, lumpectomies, or for prophylactic reasons at any point during the study, were not included for this analysis.
Two objective measurement techniques were used at each visit to quantify limb volume characteristics: circumferential measurement and infra-red perometery. Traditional anthropometric measurements recorded limb girth every 4cm on each arm using a non-stretch, flexible tape measure. Infra-red perometry (Perometer 400T/350S, Juzo, Cuyahoga Falls, OH) was used to record three-dimensional images of each limb, which were used to calculate limb volume. A detailed description of these techniques has been previously published (Armer and Stewart, 2005 ).
In addition to the two objective measures, one subjective analysis of LE symptoms was administered each visit through the LE and Breast Cancer Questionnaire (LBCQ) (Armer et al, 2003 (link)). The LBCQ, which has previously been validated, consists of 57 questions examining 19 signs and symptoms drawn from the literature and clinical observation (Armer et al, 2003 (link)). Based on these previous findings, self-report of heaviness or swelling ‘now’ or ‘in the past year’, was included as one definition for LE.
From those measurements, four criteria for identifying LE were used:
2cm circumferential change at any measured location
200ml perometry LVC of the affected arm
10% perometry LVC of the affected arm
Self-report of limb heaviness and swelling, either ‘now’ or ‘in the past year.’
Certain participants met the definitions for LE before treatment at the baseline (pre-treatment) measurement for one or more of the four criteria used. Those participants were included in the study, but not for analysis in that particular criteria, resulting in different numbers of participants for a given criteria. For example, 16 of the 211 participants met the definition for LE at baseline based on the criteria of self-reported limb heaviness and swelling, resulting in 195 participants in the subsequent self-report analysis. Also, those participants who had both right and left limbs affected due to bilateral mastectomies, lumpectomies, or for prophylactic reasons at any point during the study, were not included for this analysis.
