Evidence map›Paper›PMID 33879219›Full record

ArticleTrials2021

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial.

Pia Grabbe, Kathrin M Gschwendtner, Imad Maatouk, Sophia B Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C Hassel and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04240717 (Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 22% 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.

NCT04240717 nacompletednot on this map

Shared Decision Making on Immunotherapy in Oncology - Prospective, Randomized, Controlled Trial

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2020 to 2022Enrolled126ConditionsPatient Decision Aid, Treatment As UsualArmsPatient Decision Aid
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. eHealth Literacy in German Skin Cancer Patients.International journal of environmental research and public health · 2022
    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

11 authors at 3 institutions in 1 country.

Pia GrabbeDepartment of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany. pia.grabbe@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-1186-6956
Kathrin M GschwendtnerDepartment of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Imad MaatoukDepartment of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Sophia B StrobelNational Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.
Martin SalzmannNational Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.
Julia BossertFaculty of Medicine and University Hospital Cologne, University of Cologne, Köln, Germany.
Wolfgang EichDepartment of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Beate WildDepartment of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Friedegund MeierNational Center for Tumor Diseases, University Hospital Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
Jessica C Hassel *National Center for Tumor Diseases, University Hospital Heidelberg, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.
Christiane Bieber *Department of General Internal Medicine and Psychosomatics, Center for Psychosocial Medicine, Heidelberg University Hospital, Thibautstraße 4, 69115, Heidelberg, Germany.
Heidelberg University · DENational Center for Tumor Diseases · DEUniversity of Cologne · DE

Funding

Gemeinsamer Bundesausschuss, Innovationsausschuss 01VSF18047
6 · The paper itself

Abstract

backgroundPatients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.

methodsIn total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T DISCUSSION: This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.

trial registrationClinicalTrials.gov NCT04240717 . Registered on 27 January 2020.

Indexed as

MelanomaPatient ParticipationDecision MakingDecision Support TechniquesGermanyHumansImmunotherapyInternetMulticenter Studies as TopicRandomized Controlled Trials as TopicImmunotherapyMelanomaPatient decision aidRandomized controlled trialShared decision-making

Identifiers

PMID33879219
PMCPMC8056554
OpenAlexW3156135800

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.