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


- candidate number22865
- NTR NumberNTR5489
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2015
- Secondary IDsNL48722.018.15  CCMO-register
- Public TitleCHOICE: CHOosing treatment together In Cancer at the End of life
- Scientific TitleCHOICE: CHOosing treatment together In Cander at the End of life
- ACRONYMCHOICE
- hypothesisDisease-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.
- Healt Condition(s) or Problem(s) studiedCancer
- Inclusion criteriaPatients
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. diagnosed with metastasized or locally irresectable cancer
2. not eligible for treatment with curative intent
3. median life expectancy of <1 year without systemic treatment, and a median survival benefit of systemic treatment of <6 months. This includes, but not limited to, patients:
o with metastases or locally irresectable tumors of the pancreas, esophagus, stomach, liver, gall bladder, and bladder, and patients with metastatic sarcoma or melanoma
o patients with advanced cancer, irresective of tumour type, who have experienced progression under first line palliative systemic treatment.
4. scheduled for a consultation with a participating medical oncologist in which decisions about the start, (dis)continuation or adjustment of palliative systemic treatment will be made.
This includes consultations in which:
o a decision to start, forego or postpone a (new line of) systemic treatment will be made
o current systemic treatment is evaluated after a fixed number of cycles and a decision to (dis)continue and/or adjust systemic treatment will be made


Oncologists
Eligible are all medical oncologists (in training) treating the eligible patient population with an appointment of at least 1 year after the start of the trial.
- Exclusion criteriaPatients
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. insufficient mastery of Dutch, i.e., inability to understand the 'Gesprekswijzer' as well as the questionnaires as judged by either the physician or the researcher
2. cognitive disabilities or a psychiatric disorder that hinder understanding of the 'Gesprekswijzer' as well as the questionnaires as judged by either the physician or the researcher
3. not enough time (<2 days) to make sure the Gesprekswijzer is received before the consultation in which decisions are made
4. a primary brain tumor or brain metastasizes which significantly hinder cognitive functioning
5. being not, or no longer, eligible for (an additional line of ) palliative systemic treatment (standard or experimental)

Oncologist
Excluded will be oncologists involved in the design of the content of the interventions.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2015
- planned closingdate1-jun-2017
- Target number of participants192
- InterventionsThe 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.
- Primary outcomeObserved SDM in the audio-recorded consultation as assessed with a validated scoring instrument (OPTION) as well as a study-specific adaptation of that instrument.
- Secondary outcomea. Observed SDM in a simulated patient encounter (effect training only)
b. Patients’ perceived efficacy in communication
c. Patient and oncologist satisfaction with communication and decision making
d. Congruence between patients’ preferred and perceived role in decision making
e. Patients’ attitudes towards striving for quantity (length) or quality of life
f. Patients’ evaluation of the decision made
g. Patients’ quality of life
h. The treatment decision made
i. Patients’ trust in the oncologist
j. Patients’ anxiety
k. Patients’ fighting spirit
l. Consultation time
m. Patients'use and evaluation of the ‘Gesprekswijzer’
- TimepointsOncologists: 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.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. Inge Henselmans
- CONTACT for SCIENTIFIC QUERIESdr. Inge Henselmans
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD15-sep-2015 - 12-feb-2017


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