Cancer types
  • Head and neck
Title of study
A dedicated multidisciplinary head and neck cancer rehabilitation program compared to usual supportive care for patients treated with concomitant chemo-radiotherapy: assessment of effectiveness and cost-effectiveness in a multicenter prospective observational study
Version Number
Approval Date 
2.1, 3 June 2017
Short Title
P16HNR
Study site
Principle Investigator
A.C.C. Beck; E. Passchier
Investigator Maastro
dr. F.J.P. Hoebers
Sponsor
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

The aim of the current study is to assess the added value, in terms of effectiveness and cost-effectiveness, of this multidisciplinary HNR program compared to Usual Supportive Care (USC) provided by allied health professionals in advanced head and neck cancer (HNC) patients treated with cCRT

Primary Endpoint 

HRQoL summary score

Secondary Endpoints 

• Functional HRQoL
• Cost-effectiveness in terms of costs per quality adjusted life year (QALY), incremental costs, and incremental cost-effectiveness ratio (ICER)
• RTW
• Participation
• UN during supportive cancer care
• Clinical outcomes, including feeding tube dependency, frequency of consultations by oncological specialists and allied health professionals, hospital admissions and use of medication (taking into account adverse events)