CHOICE: CHOosing treatment together In Cancer at the End of life

Rationale: Disease-targeted treatment for metastasized or inoperable tumours offers uncertain and sometimes little benefit while treatment burden can be high. Hence, treatment decisions cannot be solely based on evidence and patients’ clinical status, but should incorporate patients’ values and preferences This requires shared decision making (SDM), an approach whereby clinician and patient exchange information and jointly deliberate to come to an agreed-upon decision. Evidence shows that SDM is not standard practice in consultations about palliative systemic treatment.



Obective; This trial aims to test the (independent and combined) effectiveness of a patient-targeted preparatory tool (‘Gesprekswijzer’) and an oncologist-targeted communication skills training to enhance SDM in consultations about palliative systemic treatment. Secondary outcomes include, among others, patient satisfaction, anxiety, efficacy and quality of life.

Study design: A pragmatic multi-center randomised controlled design with four parallel arms will be adopted. Medical oncologists will be randomised to the training or the care as usual condition. Patients (n=192 within n=24 oncologists) will be randomised to either receive the QPL or care as usual.



Study population: The study population consists of all patients with metastasized or inoperable tumours and a median life expectancy of <1 year without disease targeted treatment, for whom systemic palliative treatment does not offer median survival benefit of >6 months who meet with the oncologist to discuss either the start of (a new line) of treatment or the (dis)continuation or adjustment of current treatment.



Country of recruitment: The Netherlands



Intervention: The CHOICE skills training is provided in small groups (n=3-5) by a professional trainer and actor. It consists of a reader, two half days of training making use of modeling videos and role play, a booster session and a consultation room tool.The ‘Gesprekswijzer’ consists of a Question Prompt List and Value Clarification Exercises, i.e., two known methods to empower patients in communication and decision making.



Main study endpoint: Observed SDM in the audio-recorded consultation as assessed with a validated scoring instrument (OPTION) as well as a study-specific adaptation of that instrument.



Time points: The skills of all participating oncologists will be assessed in simulated patient encounters at two time points. Additionally, consultations with participating patients will be audiotaped and oncologists will be asked to fill out a one page questionnaire after the consultation. All participating patients will fill out questionnaires at baseline, right before the consultation, 1 week after and at 3 and 6 months post-consultation. These include measures of secondary outcomes such as patient satisfaction and quality of life. Patient's treatment status and history will be registered from their medical files at 12 months.

Disease-targeted treatment for metastasized or inoperable tumours offers uncertain and sometimes little benefit while treatment burden can be high. Hence, treatment decisions cannot be solely based on evidence and patients’ clinical status, but should incorporate patients’ values and preferences This requires shared decision making (SDM), an approach whereby clinician and patient exchange information and jointly deliberate to come to an agreed-upon decision. Evidence shows that SDM is not standard practice in consultations about palliative systemic treatment.
Objective: to test the (independent and combined) effectiveness of a patient-targeted preparatory tool (‘Gesprekswijzer’) and an oncologist-targeted communication skills training to enhance SDM in consultations about palliative systemic treatment.

Oncologists: before and after training (in control group: twice with 8 weeks in between) in a standardized patient assessment; a questionnaire after each audiorecorded consultation



Patients: questionnaires at baseline, before consultation, after consultation and at 3 and 6 months. Patient's treatment status and history will be registered from their medical files at 12 months.

The oncologist skills training is based on a four-step model of SDM and on techniques known from behavior change theories. The training is provided in small groups (n=3-5) by a professional trainer and actor. It consists of a reader, two half days of training making use of modelling videos and role play, a booster session and a consultation room tool.



The ‘Gesprekswijzer’ consists of a Question Prompt List and Value Clarification Exercises, i.e., two known methods to empower patients in communication and decision making. The booklet compirses (1) an explanation that, when cure is no longer an option, treatment decisions are highly dependent on individual preferences, (2) example question patients may wish to pose in the upcoming consultation with the oncologist and (3) questions to help patients think about their values.