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 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. The investigators estimate the physical burden/risk of this study to be negligible.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
126
The Source tool 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. 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.
Academic Medical Center
Amsterdam, North Holland, Netherlands
RECRUITINGFlevoziekenhuis
Almere Stad, Netherlands
RECRUITINGVUmc
Amsterdam, Netherlands
RECRUITINGRadiotherapiegroep
Arnhem, Netherlands
NOT_YET_RECRUITINGRijnstate
Arnhem, Netherlands
NOT_YET_RECRUITINGCatherina Ziekenhuis
Eindhoven, Netherlands
NOT_YET_RECRUITINGLUMC
Leiden, Netherlands
NOT_YET_RECRUITINGMaastro
Maastricht, Netherlands
NOT_YET_RECRUITINGRadboud UMC
Nijmegen, Netherlands
NOT_YET_RECRUITINGBVI
Tilburg, Netherlands
NOT_YET_RECRUITING...and 2 more locations
SOURCE observational scale
The SOURCE observational scale is developed to primary answer the following question: Does the combination of the tool and the training improve observed (numerical) precision of information about treatment outcomes in clinical consultations? Min. value: 1 Max. value:4 Higher scores mean higher (numerical) precision
Time frame: through study completion, an average of 1 year
Continuing professional development (CPD) reaction Questionnaire
Health care providers' intention to inform patients about treatment outcomes using numbers (effect training only)
Time frame: through study completion, an average of 1 year
Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)
Patient and physician satisfaction with communication and decision making
Time frame: 2 weeks
Shared Decision Making Questionnaire (SDMQ-9)
Patient-reported shared decision making
Time frame: 2 weeks
Decisional Conflict Scale (DCS)
Patients' evaluation of the decision made
Time frame: 2 weeks
EORTC QLQ - INFO25 + tailor made items on treatment outcome information
Patients' evaluation and knowledge of the information provided by the health care provider
Time frame: 2 weeks
EORTC QLQ-C30
Patients' health related quality of life, cancer specific
Time frame: 3 months vs. baseline
EORTC QLQ-OG25
Patients' health related quality of life, gastro-intestinal cancer specific
Time frame: 3 months vs. baseline
Trust in the Oncologist Scale (TiOS-sf)
Patients' trust in the health care provider
Time frame: 2 weeks
State-Trait Anxiety Inventory (STAI)
Patients' anxiety
Time frame: 2 weeks vs. baseline
((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)
Patients' helplessness/hopelessness + fighting spirit
Time frame: 2 weeks vs. baseline
Duration of consultation in minutes (min.)
Consultation time
Time frame: through study completion, an average of 1 year
Health care providers' personalization of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly personalizing treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of personalization
Time frame: through study completion, an average of 1 year
Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly tailoring treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of tailoring
Time frame: through study completion, an average of 1 year
Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale
Frequency of explicitly showing visualizations treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of showing visualizations
Time frame: through study completion, an average of 1 year
Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale
Presence of time frame when giving treatment outcome information, in utterances coded for the primary outcome Min. value: 0 Max. value: 1 Value 1 means time frame present, value 0 means time frame absent
Time frame: through study completion, an average of 1 year
Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale
Treatment outcome category of health care providers' treatment outcome information, in utterances coded for the primary outcome Values: Survival, Health-related Quality of Life, Side effects and complications, Progression of tumor Non-ordinal variable
Time frame: through study completion, an average of 1 year
Person initializing treatment outcome information measured with SOURCE observational scale
Person taking the initaitive for the health care provider's treatment outcome information, in utterances coded for the primary outcome Values: Health care provider, Patient Non-ordinal variable
Time frame: through study completion, an average of 1 year
Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention)
Health care providers' (numerical) precision of treatment outcome information measured in simulated patient consultations (effect intervention) Min. value: 1 Max. value:4 Higher scores mean higher (numerical) precision
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.