Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
Phase: NA
Conditions: Oesophageal Cancer, Gastric Cancer
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

 
 
 
 
SOURCE 
 
 
 
 
 
 
 
 
 
 
SOurCE 
Stimulating evidence based, personalized and tailored information 
provision to improve decision making after Oesophagogastric CancEr 
diagnosis 
- a pragmatic Stepped Wedge Trial- 
 
 
  
Version 2.3 
December, 30, 2019 
 
 
 

 
 
 
 
SOURCE 
 
 
 
Protocol ID 
 
Short title 
SOURCE 
Version 
2.3 December 2019 
Project leader 
Prof. Dr. H.W.M. Van Laarhoven 
Dept. of Medical Oncology 
Amsterdam UMC, location AMC 
Meibergdreef 9; F4-224 
1105 AZ Amsterdam 
tel:  +31 (0)20-5665955 
h.vanlaarhoven@amsterdamumc.nl 
 
Coordinating investigators 
Prof. Dr. E.M.A. Smets 
Dept. of Medical Psychology 
Amsterdam UMC, location AMC 
Meibergdreef 9; J3-220 
1105 AZ Amsterdam 
e.m.smets@amsterdamumc.nl 
 
Prof. Dr. M.A.G. Sprangers 
Dept. of Medical Psychology 
Amsterdam UMC, location AMC 
Meibergdreef 9; J3-221 
1105 AZ Amsterdam 
m.a.sprangers@amsterdamumc.nl 
 
Drs. L.F. van de Water 
Dept. of Medical Psychology 
Amsterdam UMC, location AMC 
Meibergdreef 9; J3-219 
1105 AZ Amsterdam 
l.f.vandewater@amsterdamumc.nl 
 
 
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
AMC (Amsterdam UMC) 
 
 
 

 
 
 
 
SOURCE 
 
 
 
PROTOCOL SIGNATURE SHEET 
 
Name  
Signature 
 Date 
Coordinating 
Investigator/Project 
leader/Principal Investigator: 
 
Prof. Dr. H.W.M. Van Laarhoven 
Dept. of Medical Oncology 
AMC Amsterdam 
 
 
 

 
 
 
 
SOURCE 
 
 
 
1. SUMMARY 
 
The overarching aim of the programme ‘Stimulating evidence based, personalized and tailored 
information provision to improve decision making after oesophagogastric cancer diagnosis’ (SOURCE) 
is to provide oesophagogastric cancer patients at all disease stages with evidence based and 
personalized information about survival, treatment-related side-effects and/or complications and 
health related quality of life, tailored to patients’ specific information needs, to facilitate informed 
decision making about treatment and thereby optimize personal care and outcomes. 
For this purpose the Source tool and training were designed. The Source tool is a prediction model 
based website to be used by care givers for informing patients about the outcomes of treatment. The 
Source training for care givers is designed to learn care givers how to inform patients effectively, 
especially about the outcomes of treatment.  
 
The primary aim of the SOURCE trial is to investigate the effect of the tool and training on the 
(numerical) precision of information about outcomes of treatment in the treatment information 
consultation. Secondary outcomes include: patients’ satisfaction, evaluation and knowledge of the 
information provided by the health care provider, evaluation of the decision made and health related 
quality of life. 
 
A pragmatic stepped wedge design will be used to test the effect of intervention. 21 health care 
providers will include 3 patients as control measurements (before intervention) and 3 patients as 
intervention measurements (after intervention). Participating centers will be divided into 
geographical subgroups, in which the transition period (in which the intervention will take place) will 
be spread across time. 
 
All oesophageal and gastric cancer patients scheduled for a treatment information consultation with 
a participating health care provider are suitable for inclusion and will be approached for participation 
in the SOURCE study. Measurements include audio recordings of the treatment information 
consultation and questionnaires filled in by patients and health care providers at different moments 
in time. Audio recordings will be scored and analyzed based on a study specific coding scheme. 
We estimate the physical burden/risk of this study to be negligible. 
 
 
2. INTRODUCTION AND RATIONALE 
 
Oesophagogastric cancer is a deadly disease with an increasing incidence (www.cijfersoverkanker.nl). 
Despite some improvement in survival, curative surgery results in a long-lasting deterioration in 
health related quality of life (HRQL).1 In the palliative setting, half of the patients experience a loss in 
HRQL in the first 6 months after the start of chemotherapy.2 Hence, improved survival may come 
with deterioration of HRQL.  In the curative setting, patients consider quality of life of primary 
importance and they report it may outweigh survival when deciding about treatment options.3 
Likewise, one in four patients with advanced cancer indicates that sustained or improved HRQL is 
their main treatment goal.4 To make well-informed treatment choices that match with patients’ 
preferences, information about treatment outcomes, in terms of survival, treatment-related 
morbidity and HRQL is required. Currently, however, we lack good quality outcome data on 

 
 
 
 
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oesophagogastric cancer that could be used to provide patients with personalized information, 
accommodating the specifics of their clinical and sociodemographic situation.5 Also, physician’s skills 
in providing evidence based information tailored to the specific information needs of patients merit 
improvement.6,7 Thus, we are unable to effectively provide oesophagogastric cancer patients with 
personalized information on treatment outcomes to facilitate shared decision making. 
 
The overarching aim of the programme ‘Stimulating evidence based, personalized and tailored 
information provision to improve decision making after oesophagogastric cancer diagnosis’ (SOURCE) 
is to provide oesophagogastric cancer patients at all disease stages with evidence based and 
personalized information about survival, treatment-related side-effects and/or complications and 
HRQL, tailored to patients’ specific information needs, to facilitate informed decision making about 
treatment and thereby optimize personal care and outcomes. 
 
For this purpose, we designed the Source tool and training. The Source tool is a website to be used 
by care givers for informing patients about the outcomes of treatment. Prediction models are 
developed and built in the website in order to generate a personalized prediction of the outcomes: 
survival, toxicity and/or complications and HRQL. These predictions are visualized in clear and 
comprehensible graphs with a broad variation of options available for tailoring of the visualizations. 
 
In order for care givers to be able to use this tool effectively, we designed the Source training. This 
communication skills training is comprised of an e-learning, two face-to-face group sessions and an 
individual booster session. Aside from an instruction video on the navigation within the Source tool, 
the e-learning consists of theory and tips and tricks on how to inform patients and communicate 
risks. The face-to-face components of the training are focused on getting the skilled use of the source 
tool into practice, by receiving personal feedback on the performance. Amongst the tackled 
problems are: how to tailor information to patients’ needs, how to understandably communicate risk 
while not taking away patients’ hope and how to use information in the context of a shared decision. 
 
 
3. OBJECTIVES 
 
We aim to test the effectiveness of the tool (‘Source’) and the communication skills training for 
health care providers. 
3.1. The primary research question is: 
Does the combination of the tool and the training improve observed (numerical) precision of 
information about treatment outcomes in clinical consultations? 
3.2. The secondary research questions are: 
Does the combination of tool and training affect: 
• 
Health care providers’ personalization of treatment outcome information 
• 
Health care providers’ tailoring of treatment outcome information 
• 
Health care providers’ use of visualizations 
• 
Health care providers’ setting the agenda 
• 
Health care providers’ use of time frame, initiative, treatment outcome category (on an 
utterance level) 

 
 
 
 
SOURCE 
 
 
 
• 
Health care providers’ observed (numerical) precision of information about treatment 
outcomes in simulated patient consultations (effect training only)  
• 
Health care providers’ intention to inform patients about treatment outcomes using 
numbers (effect training only) 
• 
Patient and physician satisfaction with communication and decision making  
• 
Patient-reported shared decision making  
• 
Patients’ evaluation of the decision made  
• 
Patients’ evaluation and knowledge of the information provided by the health care 
provider 
• 
Patients’ health related quality of life  
• 
Patients’ trust in the health care provider 
• 
Patients’ anxiety  
• 
Patients’ helplessness/hopelessness  
• 
Consultation time  
• 
The (provisional) treatment decision made 
 
  
Additionally we will assess: 
• 
Demographical and personal variables 
• 
Health care providers’ use of the Source tool  
• 
Health care providers’ evaluation of the Source tool 
• 
Health care providers’ evaluation of the Source training + e-learning 
 
4. STUDY DESIGN 
 
4.1. Design  
A multi-center pragmatic cluster stepped wedge design will be adopted. All health care providers will 
receive the intervention, i.e. the training and tool but at different time slots. These time slots are 
dependent on the geographical region (see Figure 1). Before the intervention takes place, a period of 
four to six months (taking the holiday season into account) will be used to include patients in order 
to collect control measurements. The subsequent transition period, in which the intervention will 
take place, will take approximately three to four months. After the intervention has taken place, 
again a period of four to six months is scheduled in which participating health care providers will 
include patients for measurements. Each participating health care provider (cluster) will include 
approximately three patients before and three patients after the intervention has taken place. The 
number of three patients per care provider is used as a mean, the minimum will be set at two 
patients and the maximum at six. The consultation with these patients will be audio recorded and 
providers and patients are asked to fill in short questionnaires before and after the consultation (see 
paragraph 7.2). In addition, each health care provider will do one simulated patient consultation 
before and one after training, which will also be recorded on audio.  
 
4.2. Duration  
Inclusion and data collection will take approximately 2 years. Figure 1 shows the planning of the 
study. 
 

 
 
 
 
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Control measurements 
 
Transition period  
 
Intervention measurements 
 
S = Simulated Patient Assessments 
 
 Figure 1. A schematic representation of the study planning over time  
 
4.3. Setting  
The study will be conducted at the medical oncology, radiotherapy and surgical departments of 
both academic and peripheral hospitals in the Netherlands.  
 
4.4. Design over time 
Figure 2 shows the design of the study over time for health care providers.  
 
 
 
 
 
 
 
Figure 2. A schematic representation of the study design over time for health care providers, 
SPA = Simulated Patient Assessment. 
 
5. STUDY POPULATION 
5.1. Population (base) 
All patients in participating centers, who have been diagnosed with oesophageal or gastric cancer 
and are scheduled for a treatment information consultation, will be asked to participate. The 
treatment information consultation is defined as the consultation in which one of the health care 
providers’ main goals is to inform the patient on the outcomes of treatment(s), for example 
when decisions about treatment have to be made.  

 
 
 
 
SOURCE 
 
 
 
All oncologists, radiotherapists and surgeons (specialists and fellows), physician assistants and 
nurse practitioners conducting these consultations with oesophageal and gastric cancer patients, 
will be asked to participate. 
 
5.2 Inclusion criteria 
 
 
Health care providers: 
- Specialist, physician assistant or nurse practitioner in the field of oncology, oncological 
radiotherapy or oncological surgery who are used to discussing treatment and treatment 
outcome with patients 
- Informed consent for data collection 
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer 
patients before the scheduled transition period (control measurements) 
- Three audiorecorded treatment information consultations with oesophageal or gastric cancer 
patients after the scheduled transition period (intervention measurements) and before the 
scheduled end date of the study 
 
 
Patients: 
- Age ≥ 18 years 
- Histological or cytological proof of oesophageal or gastric cancer 
- Informed consent for trial data collection 
A treatment information consultation with a participating doctor to discuss either curative 
treatment, first line palliative treatment, and/or best supportive care. 
 
5.3 Exclusion criteria 
 
Health care providers: 
-  Less than two control and/or intervention measurements  
 
Patients: 
- Cognitive impairment or insufficient understanding of the Dutch language 
- GIST and smallcell tumors 
 
 
5.4 Sample size calculation 
The intervention is considered successful if a significant  difference is observed in the precision of 
information about treatment outcomes provided by the health care providers (primary outcome) 
before and after the intervention. Assuming a medium sized effect (0.5 SD), an intracluster 
correlation of 0 and a power of 80%, 21 health care provider , i.e. clusters, are needed with 6 
patients per health care provider (3 control and 3 post intervention). Thus, in total 21 health care 
providers and 126 patients need to be included in the study. Based on a predicted response rate 
of 50 % 252 patients will be approached.  
 
 
6. TREATMENT OF SUBJECTS 
6.1. The Source tool 

 
 
 
 
SOURCE 
 
 
 
The Source tool is designed for use in the consultation room. It aims to assist health care 
providers with giving evidence based information about treatment outcomes by providing 
visualizations of personalized predictions of treatment outcomes for different treatments of 
oesophageal and gastric cancer. These predictions result from recently designed and updated 
prediction models on the survival, toxicity, complications and health related quality of life of 
oesophageal and gastric cancer patients.  
 
Data: 
For survival models data from the nationwide Netherlands cancer registry were used. For the 
potentially curative and palliative settings, a multivariate Cox regression models were created 
and validated according to a temporal internal-external scheme (discriminative ability (c-indices): 
0.71 for metastatic oesophagogastric cancer and 0.70 for metastatic gastric cancer, and 0.76 for 
the potentially curative models).9  
For toxicity and complications of treatments, extensive meta-analysis data were used. For 
toxicity the literature was searched for prospective phase II or III randomized controlled trials 
(RCTs) on palliative first-line systemic treatment for advanced esophagogastric cancer. All CTCAE 
1–2 (mild) and 3–4 (severe) adverse events from each chemotherapy arm were extracted and 
pooled by using single-arm meta-analysis.10 For complications of treatment, databases were 
searched for randomized controlled trials investigating curative treatment regimens for gastric 
cancer. All grade 1–2 (mild) and grade 3–5 (severe) adverse events were extracted per cytotoxic 
regimen and combined in a single-arm random-effects meta-analysis. 11 
For health related quality of life, data from the national registry on health related quality of life 
of oesophageal and gastric cancer patients (POCOP) was used to create a mixed-effects model 
with treatment as a predictor based on 725 potentially curable patients. For metastatic patients, 
data from a meta-analysis on health related quality of life in the metastatic setting is provided.12  
All models in the Source tool are updated when new, relevant data are available. 
 
Visualizations: 
• 
For survival data, both icon arrays and Kaplan Meier curves are implemented in order to 
be able to tailor the presentation format to individual patients. Adjustments to the 
displayed treatments and time period can be done, as well as to the visibility of 
confidence intervals. In the Kaplan Meier curve there is a possibility of showing three 
scenarios of survival13,14 by shading the areas under the curve. 
• 
For toxicity and complications (labeled as side effects) data, bar colored bar charts for 
both top 3 and all side effects are available. All treatments and side effects can be 
displayed separately or can be compared in one display. 
• 
For health related quality of life data, simple line graphs are available for overall quality 
of life, symptom and functioning scores. Display of time period, confidence interval and 
general population (reference) scores can be adjusted.  
• 
All visualizations can be joined in a simple overview of the three outcome categories 
(survival, side-effects, quality of life). An automatically generated text will accompany the 
graphs to serve as a summary of the communicated treatment outcomes. This overview 
can be saved as PDF or printed and handed to the patient. 
 
6.2. The Source training 

 
 
 
 
SOURCE 
 
 
 
The training aims to teach participants to inform patients about outcomes of treatment. The 
training is placed in the context of shared decision making (SDM), following the 4-step model by 
Stiggelbout et al., 2015.8 
The training is provided in small groups (3-6 participants) by an experienced trainer and 
supported by professional actors. The training aims to address knowledge, attitude and skills. The 
learning goals of the training are: 
• 
Knowledge: After the training, the participant knows: (1) the basic theory of information 
giving (relevance, goal and tips and tricks), (2) the framework of SDM applied to both 
situations in which there is one preferred option and in which there are more 
conceivable options, (3) the do’s and don’ts when giving risk and benefit information, (4) 
the functionalities of the Source tool and the data and calculations behind the Source 
tool. 
• 
Attitude: After the training, the participant is aware of one’s goal when informing 
patients about treatment and treatment outcomes and one’s barriers to use evidence-
based information about treatment outcomes. The participant has a generally positive 
attitude towards using evidence based information about treatment outcomes and is 
willing/motivated to use this information (by using the Source tool) in one’s own 
consultations. 
• 
Skills: After the training, the participant is capable of applying the required (risk) 
information giving skills in consultations about treatment and treatment outcomes and is 
able to use evidence-based information when doing so. These two learning goals include: 
(1) giving evidence-based information in a manner which patients can understand, while 
not taking away all their hopes, (2) tailoring the amount and content of the information 
to individual patients’ needs, (3) using information giving skills to facilitate patients 
decision making.  
 
 
 
The training includes:  
1. Access to an e-learning providing theory and tips and tricks 
2. Two half-day training sessions with instruction, role play and personal feedback 
3. An individual (or pairwise) booster session of 1 hour  
4. Access to an online consultation room tool, providing evidence-based information on 
outcomes of treatment for oesophageal and gastric cancer patients (the Source tool, see 6.1)  
 
 
7. METHODS 
7.1. Study parameters/endpoints 
7.1.1. 
Main study parameters/endpoints  
The primary outcome is (numerical) precision of information about outcomes of treatment in the 
treatment information consultation. To observe this, we will audiotape and content code the 
consultation, using the SOURCE observational scale, to assess the primary outcome.  
 
7.1.2. 
Consultation - secondary study parameters/endpoints 

 
 
 
 
SOURCE 
 
 
 
• 
Health care providers’ personalization of treatment outcome information (SOURCE 
observational scale) 
• 
Health care providers’ tailoring of treatment outcome information to patients’ 
information need (SOURCE observational scale) 
• 
Health care providers’ use of visualizations (SOURCE observational scale) 
• 
Health care providers’ setting the agenda (SOURCE observational scale) 
• 
Utterance level: health care providers’ use of time frame, initiative for discussing 
outcomes (health care provider, patient, informal caregiver), treatment outcome 
category discussed (survival, side-effects, quality of life) (SOURCE observational scale) 
• 
Consultation time  
 
7.1.3. 
Health care provider - secondary study parameters/endpoints   
• 
Health care providers’ satisfaction with communication and decision making (Patient 
Satisfaction Questionnaire (PSQ-5 doctor version)) 
• 
Health care providers’ use of the Source tool (observation) 
• 
Health care providers’ evaluation of the Source tool (tailor made evaluation 
questionnaire) 
• 
Health care providers’ evaluation of the Source e-learning (tailor made evaluation 
questionnaire) 
• 
Health care providers’ evaluation of the Source face-to-face training (tailor made 
evaluation questionnaire) 
• 
Health care providers’ intention to inform patients about treatment outcomes using 
numbers (effect training only) (CPD reaction questionnaire) 
 
7.1.4. 
Patient – secondary study parameters/endpoints  
• 
Patient satisfaction with communication and decision making (Patient Satisfaction 
Questionnaire (PSQ-5)) 
• 
Patients’ evaluation and knowledge of the information provided by the health care 
provider (INFO-25 + tailor made items on information about outcomes of treatment) 
• 
Patient-reported shared decision making (Shared Decision Making Questionnaire (SDMQ-
9)) 
• 
Patients’ evaluation of the decision made (Decisional Conflict Scale (DCS)) 
• 
Patients’ health related quality of life (EORTC QLQ-C30 + EORTC QLQ-OG25) 
• 
Patients’ trust in the health care provider (Trust in the Oncologist Scale (TiOS-sf)) 
• 
Patients’ anxiety (State-Trait Anxiety Inventory (STAI)) 
• 
Patients’ helplessness/hopelessness + fighting spirit ((Mini-)Mental Adjustment to Cancer 
scale ((Mini-)MAC)) 
• 
Patients’ (provisional) treatment decision (medical record) 
 
7.1.5. 
Demographical and personal study parameters  
Health care providers: 
• 
Age  
• 
Gender  

 
 
 
 
SOURCE 
 
 
 
• 
Nationality  
• 
Level of medical training/ job position 
• 
Specialism 
• 
Earlier communication skills training 
 
Patients: 
• 
Tumour location  
• 
Age  
• 
Gender  
• 
Personal living situation  
• 
Number of children (under 18)  
• 
Nationality  
• 
Educational level  
• 
Perceived efficacy in communication before the consultation  
• 
Information need 
• 
Experience with graphs/numbers 
 
7.2. Study procedures 
7.2.1. Patient study procedures 
Patients with oesophageal or gastric cancer who are scheduled for a treatment information 
consultation, will be approached by telephone for informed consent by a SOURCE research 
employee. Informed consent forms together with the information letter and the baseline T0 
questionnaire will be sent to the patient by mail or email.  
Consenting patients will be asked to fill in a questionnaire at home before the start of the 
consultation (T0 P; 7-15 minutes) and one in the waiting room, just before the start of the 
consultation (T1 P; 3-5 minutes). 
Together with receiving T1, patients will receive an envelope containing the T2 questionnaire (10-
20 minutes). Patients will be asked to fill in the T2 questionnaire within a time period of two 
weeks after the consultation. The treatment information consultation will be audio recorded. 
Dependent on the procedures as agreed upon with the participating centers, either the research 
nurse of the participating center or a researcher of the SOURCE study will facilitate the audio-
recording and questionnaire completion. 
Three months after the consultation, patients will be asked to fill in the last questionnaire (T3 P; 
10-15 minutes). Patients participating in the POCOP trial will not receive this questionnaire. For 
these patients, the data from the T2 questionnaire will be acquired through the POCOP database. 
 
7.2.2. Health care provider study procedures 
Patient inclusion 
After informed consent is signed by the health care provider, each consultation with a 
participating patient will be recorded on audio. After the consultation, health care providers will 
fill in a short questionnaire (T2 HCP; 1-2 minutes) on their evaluation of the consultation. Health 
care providers’ use of Source tool, will be logged. Each action will be logged and labeled by 

 
 
 
 
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moment in time. Entered patient data and health care providers’ study code will be stored using 
512-bit RSA encryption. 
 
Simulated patient assessment 1 (before intervention) 
During the control measurement period (see Figure 2), the first simulated patient assessment 
(SPA) will take place, which will be recorded on audio. At the first SPA, health care providers will 
be asked to fill in T1 HCP (3-5 minutes). After the consultation, health care providers will also fill in 
T2 HCP.  
 
Transition period 
After completion of the e-learning, health care providers will be asked to fill in a short evaluation 
questionnaire on the e-learning (T3 HCP; 5-10 minutes).  
 
Simulated patient assessment 2 (after intervention) 
After training is completed, the second SPA will take place. At the second simulated patient 
assessment, health care providers will fill in T4 HCP (5-10 minutes) and T2 HCP.  
 
End of study 
Lastly, at completion of their patient inclusion, health care providers will fill in a short evaluation 
of the tool (T5 HCP; 5-10 minutes). 
 
7.3. Withdrawal of individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any 
consequences. The investigator can decide to withdraw a subject from the study for urgent 
medical reasons. 
 
7.4. Replacement of individual subjects after withdrawal 
Participating patients will only be replaced after withdrawal if the minimum of 126 audio recoded 
consultations in total or the minimum of 2 control measurements and 2 interventions 
measurements per health care provider is not reached. 
Participating health care providers that did not succeed in including 2 control measurements and 
2 interventions measurements will only be replaced if the minimum of 21 in total is not reached. 
Health care providers who withdraw during the study will only be replaced if they drop out after 
informed consent, but before training. 
 
7.5. Premature termination of the study 
 
Not applicable, as we do not expect the study to be terminated prematurely due to proven un-
safety. 
 
8. SAFETY REPORTING 
The investigator will inform the subjects if anything occurs, on the basis of which it appears that 
the disadvantages of participation may be significantly greater than was foreseen in the research 

 
 
 
 
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proposal. Safety of the participants will be reconsidered and if considered insufficient, the study 
will be suspended. The investigator will take care that all subjects are kept informed. 
 
9. STATISTICAL ANALYSIS 
9.1. Primary study parameter 
Audio tapes of consultations will be analyzed, using Noldus’ The Observer XT software, on the 
primary outcome. Time-based analysis on all utterances of information on treatment outcomes is 
performed. Each utterance will receive a code based on the study specific coding scheme. 
Utterance scores will be summarized on the level of the consultation and compared between 
control and intervention measurements in a within-subjects analysis. Effects with one-sided p-
values < .05 will be considered significant; 95CI’s as well as effect sizes will be provided. 
Baseline differences across the compared patient groups on socio-demographic (age, gender, 
educational level, etc.) and clinical characteristics (cancer phase at time of the consultation, time 
since diagnosis, etc.) as well as patients’ baseline measures will be examined with the appropriate 
statistical tests (ANOVA, Chi-squared tests). All analyses of effectiveness will be controlled for 
specialization of the health care provider, profession of the health care provider (specialist, 
fellow, nurse specialist, physician assistant) and center specific characteristics (academical or 
peripheral hospital, starting time of intervention). 
Reasons for missing data will be registered and recorded. Dependent on the type of missing data, 
the appropriate procedures will be used. If necessary, multiple imputation could be applied. 
9.2. Secondary study parameters  
The secondary outcomes based on the consultation, both on the level of the utterance or the 
level of the consultation) will be coded likewise by the study specific coding scheme. Effects of the 
intervention on the outcomes will be analyzed in the same manner as the effect on the primary 
outcome (see 9.1). 
The effect on the secondary outcomes measured by patient or health care provider self-report 
will be analyzed in multi-level regression analysis.   
The effect of the training on the observed (numerical) precision of information about outcomes of 
treatment in simulated patient encounters will be assessed by using a repeated measure ANOVA. 
To answer questions regarding the evaluation of the intervention (tool and training), the 
appropriate descriptive statistics will be used (medians,  percentages). 
 
 
10. ETHICAL CONSIDERATIONS 
 
10.1. 
Recruitment and consent 
All procedures, including the interventions and questionnaires, were tested in a pilot study 
(2019). 
 
10.1.1. 
Health care providers 
Health care providers will be informed about the study and asked for consent by the investigator, 
both face-to-face and on paper. All health care providers will be invited to participate in a 

 
 
 
 
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standardized patient assessment, an e-learning, two training half-days, one booster session and 
again one standardized patient assessment. Accreditation for this training will be available. 
 
10.1.2. 
Patients for the booster sessions  
In the booster session for the training, an audio recording of a consultation will be used to 
provide the health care providers with personalized feedback. Each of the health care providers 
in the training condition will ask 1 patient for permission to audio record the consultation. The 
health care provider, the research nurse or the research associate will inform the patients about 
the purpose of the recording (training the health care provider) by telephone (depending on the 
logistical agreements with the individual center). Patients will receive a written informed consent 
form from a research associate, the research nurse or the health care provider in the waiting 
room . The nurse or research associate won’t be present during the consultation. Recordings will 
be destroyed after the booster session, and won’t be part of the study dataset.  
 
10.1.3. 
Patients in the trial  
1. Invitation.  
Eligible patients will be identified from the outpatient clinic agendas of the participating health 
care providers by either the health care provider, a research nurse or a research associate 
(depending on the logistical agreements with the individual center). If possible, the treating 
health care provider will be asked for permission to contact the patient. Since the role of treating 
health care provider is not in every case divided before consultation, this cannot always be 
realized.  
Either the research nurse of the research associate will contact the patient by telephone, explain 
the study and invite to participate. We strive to allow patients at least 3 days’ time to consider 
their participation in the study and therefore preferably contact the patient as soon as the 
consultation is planned. Via telephone, patients will be informed about the nature and goal of 
the study. Patients who consent, will be contacted by post. All subsequent (postal) contact will 
be arranged by the coordinating investigators in the Amsterdam UMC, location AMC.  
 
2. Informed consent and baseline questionnaire.  
After oral consent, patients will receive a written information letter with information about the 
study, informed consent forms and the baseline questionnaire (T0 P) to be filled in at home, 
accompanied by a return envelope. Since time between initial contact and consultation is often 
short, patients will not in every case be able to fill in the informed consent forms and the 
baseline questionnaire before consultation. Patients will still receive a written information letter 
with information about the study, informed consent forms and T0 P but will in this case be asked 
to fill these in when meeting the research associate in the waiting room for T1 P. By signing 
informed consent patients and their family agree to the collection of audio recording and 
questionnaire data.  
 
3. Waiting room.  
A research associate or research nurse will meet the patient (and their family) in the waiting 
room, and check for the filling in of informed consent forms as well as the baseline 
questionnaire. Patients will again be given the opportunity to ask questions. Patients will be 
informed about the procedure of recording the consultation (and the small audio recorder will be 

 
 
 
 
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shown). The associate or nurse will check whether the family members present have provided 
consent for audio recording the consultation. The patient will be asked to fill out a two page 
questionnaire (T1 P). In addition, the patient will receive the post-consultation questionnaire (T2 
P) with a return envelope.  
 
4. Audio recording.  
Prior to the outpatient clinic appointment, the health care provider will be informed about the 
fact that the patient is participating in SOURCE and that the consultation will be audio-recorded. 
Either the research associate, the research nurse or the health care provider will operate the 
recorder (depending on local agreements). If done by a research nurse or associate, they won’t 
be present during the consultation. Patient and family won’t be approached after the 
consultation. Encrypted audio devices will be used as soon as available to prevent access after 
the recording has been saved on the device. All audio recordings will as soon after the 
consultation as possible be filed in a strict protective digital repository.  
 
5. Follow up.  
Patients will receive one more follow-up questionnaires at 3 months post- consultation (T3 P). 
Their medical files will be checked for information about treatment until 12 months post- 
consultation, either by a research associate or a research nurse.  
 
10.2. 
Compensation for injury 
Not applicable, as this is a non-WMO study and participating in the study is without risks. We 
estimate the physical burden/risk to be none. We are aware of a potential 
emotional/psychological burden for participants. Yet, we estimate the chance of any persistent 
harmful effect to be negligible. We have taken care to minimize the confrontational nature of the 
study material. We have conducted a pilot study on the study procedures, the interventions and 
the questionnaires. Moreover, potential participants will be informed about the topic of the 
study, i.e. doctor-patient communication. Participants can voluntarily decide if they feel up to 
participation, and they can leave the study at any time for any reason if they wish to do so 
without any consequences. In case of psychological distress, participants will be referred to the 
locally available support. Also, the investigator can decide to withdraw a subject from the study if 
he/she thinks that is in the best interest of the participant. Based on this argumentation, we 
estimate the risk of participation to be negligible. 
 
11. ADMINASTRIVE ASPECTS AND PUBLICATION 
 
11.1. 
Handling and storage of data and documents  
The investigator ensures that the handling of personal data complies with the Dutch Personal 
Data Protection Act. Patients will be assigned a unique code which will be used on all documents, 
and which does not contain any personal information such as date of birth or names. The 
investigator holds the key to the code in a locked file stored separately from data. Data will be 
stored for 15 years.  
 
11.2. 
Amendments  

 
 
 
 
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Amendments are changes made to the research after a favorable opinion by the accredited 
METC has been given. All amendments will be notified to the METC that gave a favorable 
opinion.  
 
11.3. 
 Public disclosure and publication policy  
Investigators are entitled to disseminate the findings of the study via publications in reputable 
scientific journals and via presentations at seminars or scientific conferences. The investigators 
carry final responsibility for the scientific content of the publication on the main findings of the 
study. No limitations to the disclosure and publication of the findings have been imposed by the 
sponsor. The trial will be registered in a public trial registry. From each of the eleven participating 
centers, one co-author is permitted to join the publication of results. 
Finally, the SOURCE study is endorsed by the Dutch Upper GI Cancer Group (DUCG). 
 
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