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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.
BMC Cancer. 2018 01 08; 18(1):55.BC

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).

Authors+Show Affiliations

Department of Medical Psychology, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands. I.Henselmans@amc.uva.nl.Department of Medical Psychology, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.Department of Medical Psychology, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29310605

Citation

Henselmans, I, et al. "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." BMC Cancer, vol. 18, no. 1, 2018, p. 55.
Henselmans I, Smets EMA, de Haes JCJM, et al. 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. BMC Cancer. 2018;18(1):55.
Henselmans, I., Smets, E. M. A., de Haes, J. C. J. M., Dijkgraaf, M. G. W., de Vos, F. Y., & van Laarhoven, H. W. M. (2018). 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. BMC Cancer, 18(1), 55. https://doi.org/10.1186/s12885-017-3838-8
Henselmans I, et al. 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. BMC Cancer. 2018 01 8;18(1):55. PubMed PMID: 29310605.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Henselmans,I, AU - Smets,E M A, AU - de Haes,J C J M, AU - Dijkgraaf,M G W, AU - de Vos,F Y, AU - van Laarhoven,H W M, Y1 - 2018/01/08/ PY - 2017/03/04/received PY - 2017/11/23/accepted PY - 2018/1/10/entrez PY - 2018/1/10/pubmed PY - 2018/8/9/medline KW - Advanced cancer KW - Doctor-patient communication KW - Palliative medicine KW - Patient education KW - Patient participation KW - Shared decision making KW - Skills training KW - Systemic treatment SP - 55 EP - 55 JF - BMC cancer JO - BMC Cancer VL - 18 IS - 1 N2 - 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). SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/29310605/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_ L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3838-8 DB - PRIME DP - Unbound Medicine ER -