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van CCT (UK)

van CCT (UK)

(Cost-)effectiveness of an interdisciplinary head and neck rehabilitation program compared to usual supportive care for head and neck cancer patients

- candidate number28764
- NTR NumberNTR7140
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2018
- Secondary IDsP16HNR METC van het Antoni van Leeuwenhoek
- Public Title(Cost-)effectiveness of an interdisciplinary head and neck rehabilitation program compared to usual supportive care for head and neck cancer patients
- Scientific TitleA 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
- hypothesisFirst, we hypothesize that IHNR will shorten the time to regain (baseline) HRQoL.

Second, we hypothesize that the program will enhance the ability to resume work-related and daily activities, and will lead to a reduction in medical consumption (e.g. tube feeding) and adverse events (e.g. occurrence of pneumonias).

Third, we expect that these improvements will result in a reduction of hospital- and society-related costs, resulting in more cost-effectiveness compared to USC.
- Healt Condition(s) or Problem(s) studiedQuality of life, Head and Neck Squamous Cell Carcinoma, Rehabilitation
- Inclusion criteria- Patients (18 years or older) diagnosed with advanced head and neck squamous cell carcinoma (HNSCC; stage 3 and 4)
- Patients are treated with primary chemoradiotherapy (Cisplatin or Carboplatin) or bioradiotherapy (Cetuximab) with curative intent
- Exclusion criteria- Patients who are unwilling to cooperate
- Patients who are unable to take part in the program due to a language barrier or an interfering psychiatric or psychological disorder are excluded from the study
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2017
- planned closingdate1-feb-2019
- Target number of participants128
- Interventions- Intervention group: Interdisciplinary head and neck rehabilitation program (IHNR)
- Control group: Usual supportive care
- Primary outcome- Health-related quality of life expressed in the EORTC QLQ-C30 summary score.
- Secondary outcome- Functional health-related quality of life
- Cost-effectiveness
- Return to work
- Societal participation
- Unmet needs of the patient
- Patient satisfaction
- Clinical outcomes (e.g. adverse events, hospital admissions)
- Timepoints- Baseline: at diagnosis (T0)
- Follow-up: 3 (T1), 6 (T2), 9 (T3) and 12 (T4) months after start of oncological treatment
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Netherlands Cancer Institute (NKI)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute (NKI), Authors Beck/Passchier/Stuiver, non-restricted grant from ATOS Medical Sweden
- PublicationsFeasibility study of IHNR: PMID 26024692
- Brief summaryIntroduction
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 patientsí functioning, and to optimize health-related quality of life (HRQoL). It applies an integrated approach to define patientsí 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.

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-5L, and study-specific questionnaires, respectively. Both patient groups 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.

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-) effectiveness, national provision of the program can probably be advised.
- Main changes (audit trail)
- RECORD4-apr-2018 - 24-apr-2018

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