Evidence map›Paper›PMID 31269918›Full record

ArticleBMC cancer2019

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.

Ann-Jean C C Beck, Ellen Passchier, Valesca P Retèl, Martijn M Stuiver, Lisette van der Molen, Willem M C Klop, Arash Navran, Wim H van Harten, Michiel W M van den Brekel

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04617678 (A Comprehensive Approach to Head and Neck Cancer Prehabilitation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04617678 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

TypeinterventionalSponsorSanford HealthRan2021 to 2026Enrolled80ConditionsCancer of Head and NeckArmsPrehabilitation Program
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ann-Jean C C BeckDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands. a.beck@nki.nl.ORCID http://orcid.org/0000-0002-1301-9603
Ellen PasschierDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.
Valesca P RetèlDivision of Psychosocial Research and Epidemiology, the Netherlands Cancer Institute, Amsterdam, the Netherlands.
Martijn M StuiverDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.
Lisette van der MolenDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.
Willem M C KlopDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.
Arash NavranDepartment of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Wim H van HartenDivision of Psychosocial Research and Epidemiology, the Netherlands Cancer Institute, Amsterdam, the Netherlands.
Michiel W M van den BrekelDepartment of Head and Neck Surgery and Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince 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.

methodsThis 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 registrationThe study has been retrospectively registered in the Netherlands Trial Registry on April 24th 2018 ( NTR7140 ).

Indexed as

Multicenter Studies as TopicObservational Studies as TopicQuality of LifeActivities of Daily LivingCarcinoma, Squamous CellCost-Benefit AnalysisHead and Neck NeoplasmsHumansNetherlandsPatient SatisfactionProgram DevelopmentProspective StudiesReturn to Work(cost-) effectivenessHead and neck cancerInterdisciplinary careMultidisciplinary careQuality of lifeRehabilitationReturn to workSocietal participation

Identifiers

PMID31269918
PMCPMC6610831

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.