Development and prospective evaluation of CAPLET, a cancer ambulatory patient physical function longitudinal evaluation tool for routine clinical practice
- 120 Downloads
A patient’s physical function is a critical outcome variable for measuring and improving chronic care management. However, patient-reported outcome measures of physical function are not routinely assessed in cancer outpatients, in part due to limitations of tools available. This study presents the development and evaluation of the Cancer Ambulatory Patient Physical Function Longitudinal Evaluation Tool (CAPLET) as an adaptive response tool for routinely screening for physical dysfunction in oncology clinical practice.
In phase 1, 407 adult outpatients at Princess Margaret Cancer Centre completed the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI), EuroQuol-5D-3L ( EQ-5D-3L), and patient-reported outcome (PRO)-Eastern Cooperative Oncology Group (ECOG). CAPLET was developed based on a branching logic algorithm navigating patients to appropriate domains of HAQ-DI/WHOAS using their responses to the PRO-ECOG/EQ-5D-3L as screeners. Sensitivity/specificity of CAPLET screeners for HAQ-DI/WHODAS items were reported. In phase 2, CAPLET vs the WHODAS/HAQ-DI were alternatively administrated to 318 adult outpatients in a two-arm trial comparing time to completion and acceptability between the tools.
Using a patient’s ECOG status and the sum of the mobility, self-care, and usual activity dimensions of the EQ-5D-3L to dichotomize patients as with or without difficulty, CAPLET achieved a sensitivity > 90% against recommended WHODAS and HAQ-DI cutoffs for significant dysfunction. Sensitivity of screeners for capturing dysfunction in individual WHODAS/HAQ-DI items ranged from 85 to 100%. Compared to the HAQ-DI/WHODAS, CAPLET was associated with a 50% reduction in administration times and improved patient acceptability, while reducing question burden by 84% for half the sample population.
CAPLET improves the feasibility of capturing detailed assessments of patient-reported physical function in cancer outpatients.
KeywordsPhysical function Patient reported outcome Cancer Computer logic Sensitivity Specificity
This project was completed with support from Cancer Care Ontario, the Ontario Patient-Reported Outcomes for Symptoms and Toxicity Applied Clinical Research Unit (CCO ON-PROST ACRU), Lucy Wong Fund, Posluns Family Fund, and Alan B. Brown Chair in Molecular Genomics.
Compliance with ethical standards
All study protocols were approved by the research ethics board of the University Health Network in Toronto, Ontario, Canada.
A portion of the data included in this manuscript has been presented (1) at the American Society of Clinical Oncology Survivorship Symposium, January 29, 2017 and (2) at the American Society of Clinical Oncology Quality Care Symposium.
Conflict of interest
The authors declare that they have no conflict of interest.
- 3.Elliott D, Berney S, Harrold M, Skinner EH (2015) Key measurement and feasibility characteristics when selecting outcome measures. Current Physical Medicine and Rehabilitation Reports 3:255–267Google Scholar
- 5.Basch E, Snyder C, McNiff K, Brown R, Maddux S, Smith ML, Atkinson TM, Howell D, Chiang A, Wood W, Levitan N, Wu AW, Krzyzanowska M (2014) Patient-reported outcome performance measures in oncology. JOP 10:209–211. https://doi.org/10.1200/JOP.2014.001423
- 6.Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St. Germain D, O’Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D (2014) Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JNCI 106(9):dju244Google Scholar
- 7.Repetto L, Fratino L, Audisio RA, Venturino A, Gianni W, Vercelli M, Parodi S, Dal Lago D, Gioia F, Monfardini S, Aapro MS, Serraino D, Zagonel V (2002) Comprehensive geriatric assessment adds information to Eastern Cooperative Oncology Group performance status in elderly cancer patients: an Italian Group for Geriatric Oncology Study. J Clin Oncol 20:494–502CrossRefGoogle Scholar
- 9.Federici S, Bracalenti M, Meloni F, Luciano JV (2016) World Health Organization disability assessment schedule 2.0: an international systematic review. Disabil Rehab 39(23):2347–2380Google Scholar
- 11.Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376CrossRefGoogle Scholar
- 14.Bass M, Morris S, Neapolitan R (2015) Utilizing multidimensional computer adaptive testing to mitigate burden with patient reported outcomes. AMIA Annu Symp Proc 2015:320–328Google Scholar
- 15.Petersen MA, Groenvold M, Aaronson NK, Chie W, Conroy T, Costantini A, Fayers P, Helbostad J, Holzner B, Kaasa S, Singer S, Velikova G, Young T (2010) Development of computerised adaptive testing (CAT) for the EORTC QLQ-C30 dimensions—general approach and initial results for physical functioning. Eur J Cancer 46:1352–1358. https://doi.org/10.1016/j.ejca.2010.02.011 CrossRefPubMedGoogle Scholar
- 16.Helbostad JL, Holen JC, Jordhoy MS, Ringdal GI, Oldervoll L, Kaasa S, European Association for Palliative Care (EAPC) Research Network (2009) A first step in the development of an international self-report instrument for physical functioning in palliative cancer care: a systematic literature review and an expert opinion evaluation study. J Pain Symptom Manag 37:196–205CrossRefGoogle Scholar
- 18.Schubert CC, Gross C, Hurria A (2008) Functional assessment of the older patient with cancer. Oncology (Williston Park) 22:22 discussion 925, 928Google Scholar
- 19.Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R (2016) Focusing on Core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms. Clin Cancer Res 22:1553–1558CrossRefGoogle Scholar
- 22.Stucki G, Cieza A (2004) The international classification of functioning, disability and health (ICF) core sets for rheumatoid arthritis: a way to specify functioning. Ann Rheum Dis 63(Suppl 2):ii45Google Scholar
- 23.Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C (2012) Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev (8):CD007566. doi:CD007566Google Scholar
- 25.Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M, MHADIE consortium (2010) Validation of the “World Health Organization Disability Assessment Schedule, WHODAS-2” in patients with chronic diseases. Health Qual Life Outcomes 8:51CrossRefGoogle Scholar
- 31.Naik H, Qiu X, Brown MC, Mahler M, Hon H, Tiessen K, Thai H, Ho V, Gonos C, Charow R, Pat V, Irwin M, Herzog L, Ho A, Xu W, Howell D, Seung SJ, Liu G, Mittmann N (2016) Cancer patients? Willingness to routinely complete the EQ-5D instrument at clinic visits. J Popul Ther Clin Pharmacol 23:e204Google Scholar
- 32.Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J (2013) Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study 22:1717–1727. doi: https://doi.org/10.1007/s11136-012-0322-4.
- 33.Patel S, Park H, Bonato P, Chan L, Rodgers M (2012) A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil 20(9):21Google Scholar