Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo- or bioradiotherapy

Autor: Ellen Passchier, Willem M.C. Klop, Wim H. van Harten, Lisette van der Molen, Arash Navran, Michiel W. M. van den Brekel, Ann Jean C.C. Beck, Martijn M. Stuiver, Valesca P. Retèl
Přispěvatelé: Graduate School, APH - Health Behaviors & Chronic Diseases, APH - Quality of Care, Master Evidence Based Practice, Maxillofacial Surgery (AMC), Amsterdam Movement Sciences - Restoration and Development, MKA AMC (OII, ACTA), Urban Vitality, Health Technology & Services Research
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Quality of life
Cancer Research
medicine.medical_specialty
SDG 16 - Peace
Return to work
Cost effectiveness
medicine.medical_treatment
Cost-Benefit Analysis
lcsh:RC254-282
03 medical and health sciences
Study Protocol
0302 clinical medicine
Patient satisfaction
Quality of life (healthcare)
Multidisciplinary approach
Health care
Activities of Daily Living
Genetics
medicine
Humans
Multicenter Studies as Topic
Prospective Studies
Program Development
Interdisciplinary care
Head and neck cancer
Netherlands
Rehabilitation
business.industry
(cost-) effectiveness
SDG 16 - Peace
Justice and Strong Institutions
Multidisciplinary care
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Justice and Strong Institutions
Observational Studies as Topic
030104 developmental biology
Oncology
Head and Neck Neoplasms
Patient Satisfaction
030220 oncology & carcinogenesis
Societal participation
Physical therapy
Carcinoma
Squamous Cell
Observational study
business
Zdroj: BMC Cancer, Vol 19, Iss 1, Pp 1-10 (2019)
BMC cancer, 19(1):655. BioMed Central
Beck, A-JCC, Passchier, E, Retèl, V P, Stuiver, M M, van der Molen, L, Klop, W M C, Navran, A, van Harten, W H & van den Brekel, M W M 2019, ' Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo-or bioradiotherapy ', BMC Cancer, vol. 19, no. 1, 655 . https://doi.org/10.1186/s12885-019-5874-z
BMC Cancer, 19(1):655. BioMed Central
BMC Cancer
BMC Cancer, 19:655. BioMed Central
BMC cancer, 19(1):655. BioMed Central Ltd.
ISSN: 1471-2407
DOI: 10.1186/s12885-019-5874-z
Popis: BACKGROUND: Since 2011, a tailored, interdisciplinary head and neck rehabilitation (IHNR) program, covered by the basic healthcare insurance, is offered to advanced head and neck cancer (HNC) patients in the Netherlands Cancer Institute (NKI). This program is developed to preserve or restore patients' functioning, and to optimize health-related quality of life (HRQoL). It applies an integrated approach to define patients' individual goals and provide rehabilitation care throughout the cancer care continuum. The aim of the current study is to assess the (cost-) effectiveness of the IHNR approach compared to usual supportive care (USC) consisting of monodisciplinary and multidisciplinary care in advanced HNC patients.METHODS: This multicenter prospective observational study is designed to compare (cost-)effectiveness of the IHNR to USC for advanced HNC patients treated with chemoradiotherapy (CRT) or bioradiotherapy (BRT). The primary outcome is HRQoL represented in the EORTC QLQ-C30 summary score. Functional HRQoL, societal participation, utility values, return to work (RTW), unmet needs (UN), patient satisfaction and clinical outcomes are secondary outcomes, assessed using the EORTC QLQ-H&N35, USER-P, EQ-5D-5 L, and study-specific questionnaires, respectively. Both patient groups (required sample size: 64 per arm) are requested to complete the questionnaires at: diagnosis (baseline; T0), 3 months (T1), 6 months (T2), 9 months (T3) and 12 months (T4) after start of medical treatment. Differences in outcomes between the intervention and control group will be analyzed using mixed effects models, Chi-square test and descriptive statistics. In addition, a cost-effectiveness analysis (CEA) will be performed by means of a Markov decision model. The CEA will be performed using a societal perspective of the Netherlands.DISCUSSION: This prospective multicenter study will provide evidence on the effectiveness and cost-effectiveness of IHNR compared to USC. RTW and societal participation, included as secondary outcomes, have not been studied sufficiently yet in cancer rehabilitation. Interdisciplinary rehabilitation has not yet been implemented as usual care in all centers, which offers the opportunity to perform a controlled clinical study. If demonstrated to be (cost-)effective, national provision of the program can probably be advised.TRIAL REGISTRATION: The study has been retrospectively registered in the Netherlands Trial Registry on April 24th 2018 ( NTR7140 ).
Databáze: OpenAIRE
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