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

NCT04232735 | Unknown

• 1 other identifier: W19_094#19.124
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 12

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.

Conditions

Oesophageal Cancer; Gastric Cancer

Keywords

Prediction models; Tailored information; Stepped Wedge Trial; Oesophageal cancer; Gastric cancer; Webtool; Health care provider training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Continuing professional development (CPD) reaction Questionnaire

  through study completion, an average of 1 year

• Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version)

  2 weeks

• Shared Decision Making Questionnaire (SDMQ-9)

  2 weeks

• Decisional Conflict Scale (DCS)

  2 weeks

• EORTC QLQ - INFO25 + tailor made items on treatment outcome information

  2 weeks

Other Outcomes (2)

• Observed presence of Source tool measured with SOURCE observational scale

  through study completion, an average of 1 year

• SOURCE evaluation questionnaire (tailor made evaluation questionnaire)

  through study completion, an average of 1 year

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Tool and training OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Cancer Society: collaborator

Study Sites (12)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

VUmc

Amsterdam, Netherlands

RECRUITING

Radiotherapiegroep

Arnhem, Netherlands

NOT YET RECRUITING

Rijnstate

Arnhem, Netherlands

NOT YET RECRUITING

Catherina Ziekenhuis

Eindhoven, Netherlands

NOT YET RECRUITING

LUMC

Leiden, Netherlands

NOT YET RECRUITING

Maastro

Maastricht, Netherlands

NOT YET RECRUITING

Radboud UMC

Nijmegen, Netherlands

NOT YET RECRUITING

BVI

Tilburg, Netherlands

NOT YET RECRUITING

ETZ

Tilburg, Netherlands

NOT YET RECRUITING

UMC Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• H WM van Laarhoven, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïs F. van de Water, MSc.

CONTACT

020-5665955; l.f.vandewater@amsterdamumc.nl

Hanneke WM van Laarhoven, Prof. Dr.

CONTACT

020-5665955; hvanlaarhoven@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pragmatic Stepped Wedge Design

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 18, 2020
• Study Start: October 13, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (12)