Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 16, 2020
Date Accepted: Jul 5, 2021
Development, and Evaluation of a Decision Aid to Support Patients’ Participatory Decision-making on Tumor-specific and Palliative Therapy in Advanced Cancer Patients: A Study Protocol.
ABSTRACT
Background:
To support advanced cancer patients, for whom standard therapy is no longer avail-able, and their oncologists in therapy decisions, we aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to better un-derstand risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in clinical trials.
Objective:
This study protocol outlines the development and testing of a DA in a pre-post design study targeting at a heterogeneous population of advanced cancer patients.
Methods:
In phase I, The DA will be developed after of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discus-sions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2) assessed by experts. In the last project phase, we will run a pre-post design study with n= 70 doctor-patient-encounters to access improvements on primary study outcome, i.e. patients’ level of decisional conflict. In addition, the user ac-ceptance will be tested.
Results:
Interviews with cancer patients, oncologists and health care providers have been completed.
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 patients’ inclusion in clinical trials. Clinical Trial: NCT04606238 https://clinicaltrials.gov/ct2/show/NCT04606238
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