Evidence map›Paper›PMID 34533464›Full record

ArticleJMIR research protocols2021

Development and Evaluation of a Decision Aid to Support Patients' Participatory Decision-Making for Tumor-Specific and Palliative Therapy for Advanced Cancer: Protocol for a Pre-Post Study.

Katsiaryna Laryionava, Jan Schildmann, Michael Wensing, Ullrich Wedding, Bastian Surmann, Lena Woydack, Katja Krug, Eva Winkler

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04606238 (Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life), 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
–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.

NCT04606238 naunknown statusnot on this map

Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2019 to 2023Enrolled70ConditionsAdvanced CancerArmsDecision Aid
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

8 authors.

Katsiaryna LaryionavaInstitute for History and Ethics of Medicine, Centre for Health Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.ORCID https://orcid.org/0000-0002-3431-1611
Jan SchildmannInstitute for History and Ethics of Medicine, Centre for Health Sciences, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.ORCID https://orcid.org/0000-0002-5755-7630
Michael WensingDepartment of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.ORCID https://orcid.org/0000-0001-6569-8137
Ullrich WeddingPalliative Care, Department of Internal Medicine II, University of Jena, Jena, Germany.ORCID https://orcid.org/0000-0002-0333-8643
Bastian SurmannHealth Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.ORCID https://orcid.org/0000-0003-1655-0907
Lena WoydackDepartment of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-0234-4427
Katja KrugDepartment of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.ORCID https://orcid.org/0000-0002-9795-7954
Eva Winkler *Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.ORCID https://orcid.org/0000-0001-7460-0154

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo support advanced cancer patients and their oncologists in therapeutic decisions, we aim to develop a decision aid (DA) in a multiphased, bicentric study. The DA aims to help patients to better understand risks and benefits of the available treatment options including the options of standard palliative care or cancer-specific treatment (ie, off-label drug use within an individual treatment plan).

objectiveThis study protocol outlines the development and testing of the DA in a pre-post study targeting a heterogeneous population of advanced cancer patients.

methodsIn the first step, we will assess patients' information and decisional needs as well as the views of the health care providers regarding the content and implementation of the DA. Through a scoping review, we aim to analyze specific characteristics of the decision-making process and to specify the treatment options, outcomes, and probabilities. An interdisciplinary research group of experts will develop and review the DA. In the second step, testing of the DA (design and field testing) with patients and oncologists will be conducted. As a last step, we will run a pre-post design study with 70 doctor-patient encounters to assess improvements on the primary study outcome: patients' level of decisional conflict. In addition, the user acceptance of all involved parties will be tested.

resultsInterviews with cancer patients, oncologists, and health care providers (ie, nurses, nutritionists) as well as a literature review from phase I have been completed. The field testing is scheduled for April 2021 to August 2021, with the final revision scheduled for September 2021. The pre-post study of the DA and acceptance testing are scheduled to start in October 2021 and shall be finished in September 2022.

conclusionsA unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and switching to best supportive care.

trial registrationClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24954.

Indexed as

clinical trialsdecision aidlongitudinal studyneoplasmspalliative care

Identifiers

PMID34533464
PMCPMC8486990

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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.