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Trial record 1 of 1 for:    NCT04232735
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Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) (SOURCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232735
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : December 16, 2022
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
Oesophageal Cancer Gastric Cancer Other: Tool and training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pragmatic Stepped Wedge Design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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


Secondary Outcome Measures :
  1. Continuing professional development (CPD) reaction Questionnaire [ Time Frame: through study completion, an average of 1 year ]
    Health care providers' intention to inform patients about treatment outcomes using numbers (effect training only)

  2. Patient Satisfaction Questionnaire (PSQ-5 patient and doctor version) [ Time Frame: 2 weeks ]
    Patient and physician satisfaction with communication and decision making

  3. Shared Decision Making Questionnaire (SDMQ-9) [ Time Frame: 2 weeks ]
    Patient-reported shared decision making

  4. Decisional Conflict Scale (DCS) [ Time Frame: 2 weeks ]
    Patients' evaluation of the decision made

  5. EORTC QLQ - INFO25 + tailor made items on treatment outcome information [ Time Frame: 2 weeks ]
    Patients' evaluation and knowledge of the information provided by the health care provider

  6. EORTC QLQ-C30 [ Time Frame: 3 months vs. baseline ]
    Patients' health related quality of life, cancer specific

  7. EORTC QLQ-OG25 [ Time Frame: 3 months vs. baseline ]
    Patients' health related quality of life, gastro-intestinal cancer specific

  8. Trust in the Oncologist Scale (TiOS-sf) [ Time Frame: 2 weeks ]
    Patients' trust in the health care provider

  9. State-Trait Anxiety Inventory (STAI) [ Time Frame: 2 weeks vs. baseline ]
    Patients' anxiety

  10. ((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC) [ Time Frame: 2 weeks vs. baseline ]
    Patients' helplessness/hopelessness + fighting spirit

  11. Duration of consultation in minutes (min.) [ Time Frame: through study completion, an average of 1 year ]
    Consultation time

  12. Health care providers' personalization of treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    Frequency of explicitly personalizing treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of personalization

  13. Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    Frequency of explicitly tailoring treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of tailoring

  14. Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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

  15. Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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

  16. Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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

  17. Person initializing treatment outcome information measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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

  18. Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention) [ Time Frame: through study completion, an average of 1 year ]
    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


Other Outcome Measures:
  1. Observed presence of Source tool measured with SOURCE observational scale [ Time Frame: through study completion, an average of 1 year ]
    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

  2. SOURCE evaluation questionnaire (tailor made evaluation questionnaire) [ Time Frame: through study completion, an average of 1 year ]
    Health care providers' evaluation of the Source tool, training and e-learning Min value: 1 Max value: 10 Higher scores mean better evaluations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232735


Contacts
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Contact: Loïs F. van de Water, MSc. 020-5665955 l.f.vandewater@amsterdamumc.nl
Contact: Hanneke WM van Laarhoven, Prof. Dr. 020-5665955 hvanlaarhoven@amsterdamumc.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord Holland, Netherlands, 1105AZ
Contact: Loïs F van de Water, MSc.    +31205665955    l.f.vandewater@amsterdamumc.nl   
Principal Investigator: Hanneke WM van Laarhoven, MD, PhD         
Flevoziekenhuis Recruiting
Almere, Netherlands
Contact: Loïs F van de Water, MSc.         
VUmc Recruiting
Amsterdam, Netherlands
Contact: Loïs F van de Water, MSc.         
Radiotherapiegroep Not yet recruiting
Arnhem, Netherlands
Contact: Loïs F van de Water, MSc.         
Rijnstate Not yet recruiting
Arnhem, Netherlands
Contact: Loïs F van de Water, MSc.         
Catherina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands
Contact: Loïs F van de Water, MSc.         
LUMC Not yet recruiting
Leiden, Netherlands
Contact: Loïs F. van de Water, MSc.         
Maastro Not yet recruiting
Maastricht, Netherlands
Contact: Loïs F van de Water, MSc.         
Radboud UMC Not yet recruiting
Nijmegen, Netherlands
Contact: Loïs F van de Water, MSc.         
BVI Not yet recruiting
Tilburg, Netherlands
Contact: Loïs F van de Water, MSc.         
ETZ Not yet recruiting
Tilburg, Netherlands
Contact: Loïs F van de Water, MSc.         
UMC Utrecht Not yet recruiting
Utrecht, Netherlands
Contact: Loïs F. van de Water, MSc.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Cancer Society
Investigators
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Principal Investigator: H WM van Laarhoven, Prof. Dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Study Documents (Full-Text)

Documents provided by H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Study Protocol  [PDF] December 30, 2019

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Responsible Party: H.W.M. van Laarhoven, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04232735    
Other Study ID Numbers: W19_094#19.124
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H.W.M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Prediction models
Tailored information
Stepped Wedge Trial
Oesophageal cancer
Gastric cancer
Webtool
Health care provider training
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases