A randomized controlled trial of a skills training for oncologists and a communication aid for patients to stimulate shared decision making about palliative systemic treatment (CHOICE): study protocol

I Henselmans, E M A Smets, J C J M de Haes, M G W Dijkgraaf, F Y de Vos, H W M van Laarhoven, I Henselmans, E M A Smets, J C J M de Haes, M G W Dijkgraaf, F Y de Vos, H W M van Laarhoven

Abstract

Background: Systemic treatment for advanced cancer offers uncertain and sometimes little benefit while the burden can be high. Hence, treatment decisions require Shared Decision Making (SDM). The CHOICE trial examines the separate and combined effect of oncologist training and a patient communication aid on SDM in consultations about palliative systemic treatment.

Methods: A RCT design with four parallel arms will be adopted. Patients with metastatic or irresectable cancer with a median life expectancy <12 months who meet with a medical oncologist to discuss the start or continuation of palliative systemic treatment are eligible. A total of 24 oncologists (in training) and 192 patients will be recruited. The oncologist training consists of a reader, two group sessions (3.5 h; including modelling videos and role play), a booster feedback session (1 h) and a consultation room tool. The patient communication aid consists of a home-sent question prompt list and a value clarification exercise to prepare patients for SDM in the consultation. The control condition consists of care as usual. The primary outcome is observed SDM in audio-recorded consultations. Secondary outcomes include patient and oncologist evaluation of communication and decision-making, the decision made, quality of life, potential adverse outcomes such as anxiety and hopelessness, and consultation duration. Patients fill out questionnaires at baseline (T0), before (T1) and after the consultation (T2) and at 3 and 6 months (T3 and T4). All oncologists participate in two standardized patient assessments (before-after training) prior to the start of patient inclusion. They will fill out a questionnaire before and after these assessments, as well as after each of the recorded consultations in clinical practice.

Discussion: The CHOICE trial will enable evidence-based choices regarding the investment in SDM interventions targeting either oncologists, patients or both in the advanced cancer setting. The trial takes into account the immediate effect of the interventions on observed communication, but also on more distal and potential adverse patient outcomes. Also, the trial provides evidence regarding the assumption that SDM about palliative cancer treatment results in less aggressive treatment and more quality of life in the final period of life.

Trial registration: Netherlands Trial Registry number NTR5489 (prospective; 15 Sep 2015).

Keywords: Advanced cancer; Doctor-patient communication; Palliative medicine; Patient education; Patient participation; Shared decision making; Skills training; Systemic treatment.

Conflict of interest statement

Ethics approval and consent to participate

The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The study protocol has been reviewed and approved by the Medical Ethical Committee of the coordinating center (Medical Ethics Review Committee, Academic Medical Center, University of Amsterdam; NL 48722.018.15; METC-2015-149). In line with the External Review Directive 2015 issued by the Central Committee of Research involving Human Subjects (CCMO), all participating centers have reviewed and approved local feasibility (University Medical Center Utrecht, Radboud University Medical Center Nijmegen, BovenIj Ziekenhuis Amsterdam-Noord, Flevo Ziekenhuis Almere, Catharina Cancer Institute Eindhoven, Isala klinieken Zwolle).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Assessments for oncologists and patients

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