Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

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.

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.

Tool and training

Loïs F. van de Water, MSc.

Hanneke WM van Laarhoven, Prof. Dr.

Loïs F van de Water, MSc.

Hanneke WM van Laarhoven, MD, PhD

H WM van Laarhoven, Prof. Dr.

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 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.

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

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

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

Health care providers' evaluation of the Source tool, training and e-learning Min value: 1 Max value: 10 Higher scores mean better evaluations

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

Health care providers' intention to inform patients about treatment outcomes using numbers (effect training only)

Patient and physician satisfaction with communication and decision making

Patients' evaluation of the decision made

Patients' evaluation and knowledge of the information provided by the health care provider

Patients' health related quality of life, cancer specific

Patients' health related quality of life, gastro-intestinal cancer specific

Patients' trust in the health care provider

Patients' helplessness/hopelessness + fighting spirit

Frequency of explicitly personalizing treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of personalization

Frequency of explicitly tailoring treatment outcome information, based on audio tapes Min. value: 0 Max. value: endless Higher values mean more utterances of tailoring

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

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

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

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

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

Dutch Cancer Society

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

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Prostatic Neoplasms

Breast Neoplasms

Depression

Depressive Disorder

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Patients had access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as to a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

Patients in the experimental group had over the study period access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

Patients in the control group received usual care

WebChoice

Cornelia M Ruland, PhD

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

This randomized clinical trial:

1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze:
2. Relationships between primary and secondary outcomes;
3. How patients' symptom distress varies over time;
4. Patients' preferences for participation in decision making about symptom management
5. How patients use WebChoice, such as frequency of use, duration, most used components;
6. How patients' experience WebChoice's usefulness and ease of use;
7. Patterns and content of patients' communication with the cancer nurse and other patients.

325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

Internet Support for Cancer Patients

A Randomized Clincial Trial to Evaluate the Effects of an Internett-based Support System for Cancer Patients on Symptom Distress, Depression, and Quality of Life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)	NCT04232735	Oesophageal Can... Gastric Cancer	Tool and traini...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Internet Support for Cancer Patients	NCT00710658	Cancer Breast Cancer Prostate Cancer	WebChoice	18 Years -	Oslo University Hospital
Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)	NCT04232735	Oesophageal Can... Gastric Cancer	Tool and traini...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)	NCT04232735	Oesophageal Can... Gastric Cancer	Tool and traini...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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