Evidence map›Paper›PMID 27484126›Full record

Trial reportBMC cancer2016

Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial.

Femke Jansen, Ingrid C Cnossen, Simone E J Eerenstein, Veerle M H Coupé, Birgit I Witte, Cornelia F van Uden-Kraan, Patricia Doornaert, Weibel W Braunius, Remco De Bree, José A U Hardillo and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 19% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Dysphagia Advances in Head and Neck Cancer.Current otorhinolaryngology reports · 2023
    Review
  4. Article
  5. Article
  6. Costs from a healthcare and societal perspective among cancer patients after total laryngectomy: are they related to patient activation?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    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

14 authors at 7 institutions in 1 country.

Femke JansenDepartment of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Ingrid C CnossenDepartment of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Simone E J EerensteinDepartment of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Veerle M H CoupéDepartment of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Birgit I WitteDepartment of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Cornelia F van Uden-KraanDepartment of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081, BT, Amsterdam, The Netherlands.
Patricia DoornaertDepartment of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Weibel W BrauniusDepartment of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
Remco De BreeDepartment of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.
José A U HardilloDepartment of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.
Jimmie HoningsDepartment of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.
György B HalmosDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700, RB, Groningen, The Netherlands.
C René LeemansDepartment of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands.
Irma M Verdonck-de LeeuwDepartment of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, The Netherlands. im.verdonck@vumc.nl.
Amsterdam UMC Location VUmc · NLVrije Universiteit Amsterdam · NLCancer Genomics Centre · NLErasmus MC · NLRadboud University Nijmegen · NLUniversity Medical Center Utrecht · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTotal laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy. METHODS/

designPatients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up. DISCUSSION: This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.

trial registrationNTR5255 Protocol version 4 date September 2015.

Indexed as

Cost-Benefit AnalysisDeglutition DisordersExercise TherapyFemaleHumansLaryngectomyMalePatient Education as TopicProspective StudiesQuality of LifeResearch DesignSelf CareSpeech DisordersTreatment OutcomeExercise programHead and neck cancerShoulder problemsSpeech problemsSwallowing problemsTotal laryngectomy

Identifiers

PMID27484126
PMCPMC4971642
OpenAlexW2497691802

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.