PMID- 34533464
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211022
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 9
DP  - 2021 Sep 17
TI  - 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.
PG  - e24954
LID - 10.2196/24954 [doi]
LID - e24954
AB  - BACKGROUND: To 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). OBJECTIVE: This study protocol outlines the 
      development and testing of the DA in a pre-post study targeting a heterogeneous 
      population of advanced cancer patients. METHODS: In 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. RESULTS: Interviews 
      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. CONCLUSIONS: A 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 
      REGISTRATION: ClinicalTrials.gov NCT04606238; 
      https://clinicaltrials.gov/ct2/show/NCT04606238. INTERNATIONAL REGISTERED REPORT 
      IDENTIFIER (IRRID): DERR1-10.2196/24954.
CI  - (c)Katsiaryna Laryionava, Jan Schildmann, Michael Wensing, Ullrich Wedding, Bastian 
      Surmann, Lena Woydack, Katja Krug, Eva Winkler. Originally published in JMIR 
      Research Protocols (https://www.researchprotocols.org), 17.09.2021.
FAU - Laryionava, Katsiaryna
AU  - Laryionava K
AUID- ORCID: 0000-0002-3431-1611
AD  - Institute for History and Ethics of Medicine, Centre for Health Sciences, Martin 
      Luther University Halle-Wittenberg, Halle (Saale), Germany.
AD  - Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg 
      University Hospital, Heidelberg, Germany.
FAU - Schildmann, Jan
AU  - Schildmann J
AUID- ORCID: 0000-0002-5755-7630
AD  - Institute for History and Ethics of Medicine, Centre for Health Sciences, Martin 
      Luther University Halle-Wittenberg, Halle (Saale), Germany.
FAU - Wensing, Michael
AU  - Wensing M
AUID- ORCID: 0000-0001-6569-8137
AD  - Department of General Practice and Health Services Research, Heidelberg 
      University Hospital, Heidelberg, Germany.
FAU - Wedding, Ullrich
AU  - Wedding U
AUID- ORCID: 0000-0002-0333-8643
AD  - Palliative Care, Department of Internal Medicine II, University of Jena, Jena, 
      Germany.
FAU - Surmann, Bastian
AU  - Surmann B
AUID- ORCID: 0000-0003-1655-0907
AD  - Health Economics and Health Care Management, Bielefeld University, Bielefeld, 
      Germany.
FAU - Woydack, Lena
AU  - Woydack L
AUID- ORCID: 0000-0002-0234-4427
AD  - Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg 
      University Hospital, Heidelberg, Germany.
FAU - Krug, Katja
AU  - Krug K
AUID- ORCID: 0000-0002-9795-7954
AD  - Department of General Practice and Health Services Research, Heidelberg 
      University Hospital, Heidelberg, Germany.
FAU - Winkler, Eva
AU  - Winkler E
AUID- ORCID: 0000-0001-7460-0154
AD  - Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg 
      University Hospital, Heidelberg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT04606238
PT  - Journal Article
DEP - 20210917
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8486990
OTO - NOTNLM
OT  - clinical trials
OT  - decision aid
OT  - longitudinal study
OT  - neoplasms
OT  - palliative care
COIS- Conflicts of Interest: None declared.
EDAT- 2021/09/18 06:00
MHDA- 2021/09/18 06:01
PMCR- 2021/09/17
CRDT- 2021/09/17 12:14
PHST- 2020/11/16 00:00 [received]
PHST- 2021/07/05 00:00 [accepted]
PHST- 2021/06/18 00:00 [revised]
PHST- 2021/09/17 12:14 [entrez]
PHST- 2021/09/18 06:00 [pubmed]
PHST- 2021/09/18 06:01 [medline]
PHST- 2021/09/17 00:00 [pmc-release]
AID - v10i9e24954 [pii]
AID - 10.2196/24954 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Sep 17;10(9):e24954. doi: 10.2196/24954.