Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) (SOURCE)

Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Oesophageal Cancer
• Intervention / Treatment: Other: Tool and training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loïs F. van de Water, MSc.; Phone Number: 020-5665955; Email: l.f.vandewater@amsterdamumc.nl
• Study Contact Backup: Name: Hanneke WM van Laarhoven, Prof. Dr.; Phone Number: 020-5665955; Email: hvanlaarhoven@amsterdamumc.nl

Study Locations

• Netherlands
  • Almere, Netherlands
    • Recruiting
    • Flevoziekenhuis
    • Contact: Loïs F van de Water, MSc.
  • Amsterdam, Netherlands
    • Recruiting
    • VUMC
    • Contact: Loïs F van de Water, MSc.
  • Arnhem, Netherlands
    • Not yet recruiting
    • Rijnstate
    • Contact: Loïs F van de Water, MSc.
  • Arnhem, Netherlands
    • Not yet recruiting
    • Radiotherapiegroep
    • Contact: Loïs F van de Water, MSc.
  • Eindhoven, Netherlands
    • Not yet recruiting
    • Catherina ziekenhuis
    • Contact: Loïs F van de Water, MSc.
  • Leiden, Netherlands
    • Not yet recruiting
    • LUMC
    • Contact: Loïs F. van de Water, MSc.
  • Maastricht, Netherlands
    • Not yet recruiting
    • Maastro
    • Contact: Loïs F van de Water, MSc.
  • Nijmegen, Netherlands
    • Not yet recruiting
    • Radboud UMC
    • Contact: Loïs F van de Water, MSc.
  • Tilburg, Netherlands
    • Not yet recruiting
    • BVI
    • Contact: Loïs F van de Water, MSc.
  • Tilburg, Netherlands
    • Not yet recruiting
    • ETZ
    • Contact: Loïs F van de Water, MSc.
  • Utrecht, Netherlands
    • Not yet recruiting
    • UMC Utrecht
    • Contact: Loïs F. van de Water, MSc.
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1105AZ
      • Recruiting
      • Academic Medical Center
      • Contact: Loïs F van de Water, MSc.; Phone Number: +31205665955; Email: l.f.vandewater@amsterdamumc.nl
      • Principal Investigator: Hanneke WM van Laarhoven, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuing professional development (CPD) reaction Questionnaire	Health care providers' intention to inform patients about treatment outcomes using numbers (effect training only)	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	2 weeks
Shared Decision Making Questionnaire (SDMQ-9)	Patient-reported shared decision making	2 weeks
Decisional Conflict Scale (DCS)	Patients' evaluation of the decision made	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	2 weeks
EORTC QLQ-C30	Patients' health related quality of life, cancer specific	3 months vs. baseline
EORTC QLQ-OG25	Patients' health related quality of life, gastro-intestinal cancer specific	3 months vs. baseline
Trust in the Oncologist Scale (TiOS-sf)	Patients' trust in the health care provider	2 weeks
State-Trait Anxiety Inventory (STAI)	Patients' anxiety	2 weeks vs. baseline
((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)	Patients' helplessness/hopelessness + fighting spirit	2 weeks vs. baseline
Duration of consultation in minutes (min.)	Consultation time	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	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	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	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	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	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	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	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed presence of Source tool measured with SOURCE observational scale	Health care providers' observed use of the Source tool Min. value: 0 Max. value:1 Value 0 means absence of Source tool in consultation, Value 1 means presence of Source tool in conversation	through study completion, an average of 1 year
SOURCE evaluation questionnaire (tailor made evaluation questionnaire)	Health care providers' evaluation of the Source tool, training and e-learning Min value: 1 Max value: 10 Higher scores mean better evaluations	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: H WM van Laarhoven, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2020
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Gastric cancer; Oesophageal cancer; Prediction models; Tailored information; Stepped Wedge Trial; Webtool; Health care provider training
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: W19_094#19.124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No