Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)
NCT ID: NCT04232735
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2020-10-13
2023-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Intervention
The Source tool is 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.
Tool and training
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.
Interventions
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Tool and training
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
\- Less than two control and/or intervention measurements
Patients:
* Cognitive impairment or insufficient understanding of the Dutch language
* GIST and smallcell carcinomas.
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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H.W.M. van Laarhoven
Principal Investigator
Principal Investigators
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H WM van Laarhoven, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center
Amsterdam, North Holland, Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
VUmc
Amsterdam, , Netherlands
Radiotherapiegroep
Arnhem, , Netherlands
Rijnstate
Arnhem, , Netherlands
Catherina Ziekenhuis
Eindhoven, , Netherlands
LUMC
Leiden, , Netherlands
Maastro
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
BVI
Tilburg, , Netherlands
ETZ
Tilburg, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F. van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F van de Water, MSc.
Role: primary
Loïs F. van de Water, MSc.
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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W19_094#19.124
Identifier Type: -
Identifier Source: org_study_id