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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Oesophageal Cancer; Gastric Cancer

Treatments: Other: Tool and training

Study type: Interventional

Funder types: Other

Identifiers

NCT04232735

W19_094#19.124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Other: Tool and training