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

Gastric Cancer Clinical Trial

— SOURCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232735
• Other study ID #: W19_094#19.124
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Loïs F. van de Water, MSc.
• Phone: 020-5665955
• Email: l.f.vandewater[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Oesophageal Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	Academic Medical Center	Amsterdam	Noord Holland
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

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)	Patient and physician satisfaction with communication and decision making	2 weeks
Secondary	Shared Decision Making Questionnaire (SDMQ-9)	Patient-reported shared decision making	2 weeks
Secondary	Decisional Conflict Scale (DCS)	Patients' evaluation of the decision made	2 weeks
Secondary	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
Secondary	EORTC QLQ-C30	Patients' health related quality of life, cancer specific	3 months vs. baseline
Secondary	EORTC QLQ-OG25	Patients' health related quality of life, gastro-intestinal cancer specific	3 months vs. baseline
Secondary	Trust in the Oncologist Scale (TiOS-sf)	Patients' trust in the health care provider	2 weeks
Secondary	State-Trait Anxiety Inventory (STAI)	Patients' anxiety	2 weeks vs. baseline
Secondary	((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)	Patients' helplessness/hopelessness + fighting spirit	2 weeks vs. baseline
Secondary	Duration of consultation in minutes (min.)	Consultation time	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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