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.
clinical trials
decision aid
longitudinal study
neoplasms
palliative care
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
17 Sep 2021
17 Sep 2021
Historique:
received:
16
11
2020
accepted:
05
07
2021
revised:
18
06
2021
entrez:
17
9
2021
pubmed:
18
9
2021
medline:
18
9
2021
Statut:
epublish
Résumé
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). This study protocol outlines the development and testing of the DA in a pre-post study targeting a heterogeneous population of advanced cancer patients. 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. 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. 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. ClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238. DERR1-10.2196/24954.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/24954.
Identifiants
pubmed: 34533464
pii: v10i9e24954
doi: 10.2196/24954
pmc: PMC8486990
doi:
Banques de données
ClinicalTrials.gov
['NCT04606238']
Types de publication
Journal Article
Langues
eng
Pagination
e24954Informations de copyright
©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.
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