The validation of a quality of life scale to assess the impact of arm morbidity in breast cancer patients post-operatively

This paper documents the validation of a quality of life scale (QOL) design ed to assess the impact of arm morbidity on patients following breast cance r surgery. A four item arm subscale was developed to supplement a multi-dim ensional, validated breast cancer QOL tool, the functional assessment of ca ncer therapy (FACT-B.) The new questionnaire, the FACT-B + 4, was validated on 279 women participating in a trial of sentinel node guided axillary the rapy and 29 women attending a lymphoedema clinic. The subscale demonstrated good internal consistency (alpha co-efficient = 0.62 to 0.88) and stabilit y (test-retest reliability = 0.97). Lymphoedema patients reported significa ntly greater arm problems than a matched sample of pre-operative trial part icipants. The lymphoedema group also scored lower than trial patients on th e FACT-B + 4 indicating a poorer quality of life (p < 0.05). A subset of 66 trial patients who had completed three consecutive assessments was used to evaluate the sensitivity of the questionnaire to change over time. Scores on the FACT-B + 4 were found to decline significantly between the pre-opera tive assessment and post-operative assessment at 1 month. Arm problems sign ificantly increased during this period. FACT-B + 4 score increased again fr om 1 month to 12 weeks post-surgery and symptoms reduced, as the extent of arm morbidity resolved. The FACT-B + 4 appears to be psychometrically robus t and sensitive to patient rehabilitation, making it suitable for use in lo ngitudinal surgical trials. Given the dearth of existing scales available t o measure arm morbidity, we hope this new tool will prove useful to researc hers.