Clinical trial NCT04232735: Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)
Official title: Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Cancer
Gastric Cancer
Keywords: Prediction models
Tailored information
Stepped Wedge Trial
Oesophageal cancer
Gastric cancer
Webtool
Health care provider training
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2020-01-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic Stepped Wedge Design
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

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 carcinomas.

Primary outcomes:
measure: SOURCE observational scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Continuing professional development (CPD) reaction Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)
timeFrame: 2 weeks
measure: Shared Decision Making Questionnaire (SDMQ-9)
timeFrame: 2 weeks
measure: Decisional Conflict Scale (DCS)
timeFrame: 2 weeks
measure: EORTC QLQ - INFO25 + tailor made items on treatment outcome information
timeFrame: 2 weeks
measure: EORTC QLQ-C30
timeFrame: 3 months vs. baseline
measure: EORTC QLQ-OG25
timeFrame: 3 months vs. baseline
measure: Trust in the Oncologist Scale (TiOS-sf)
timeFrame: 2 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 2 weeks vs. baseline
measure: ((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)
timeFrame: 2 weeks vs. baseline
measure: Duration of consultation in minutes (min.)
timeFrame: through study completion, an average of 1 year
measure: Health care providers' personalization of treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Person initializing treatment outcome information measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Observed presence of Source tool measured with SOURCE observational scale
timeFrame: through study completion, an average of 1 year
measure: SOURCE evaluation questionnaire (tailor made evaluation questionnaire)
timeFrame: through study completion, an average of 1 year
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: VUmc
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Eindhoven
country: Netherlands
facility: Catherina Ziekenhuis
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastro
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Tilburg
country: Netherlands
facility: BVI
city: Tilburg
country: Netherlands
facility: ETZ
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: H WM van Laarhoven, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: