Stimulating Evidence Based, Personalized and Tailored Information Provision to Improve Decision Making After Oesophagogastric CancEr Diagnosis - a Pragmatic Stepped Wedge Trial-
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 13
- 主要终点
- SOURCE observational scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Health care providers:
- •Less than two control and/or intervention measurements
- •Cognitive impairment or insufficient understanding of the Dutch language
- •GIST and smallcell carcinomas.
结局指标
主要结局
SOURCE observational scale
时间窗: 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
次要结局
- State-Trait Anxiety Inventory (STAI)(2 weeks vs. baseline)
- Health care providers' use of visualizations of treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- Shared Decision Making Questionnaire (SDMQ-9)(2 weeks)
- EORTC QLQ - INFO25 + tailor made items on treatment outcome information(2 weeks)
- EORTC QLQ-C30(3 months vs. baseline)
- ((Mini-)Mental Adjustment to Cancer scale ((Mini-)MAC)(2 weeks vs. baseline)
- Health care providers' personalization of treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- Decisional Conflict Scale (DCS)(2 weeks)
- Health care providers' use of time frames when giving treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- 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)
- Trust in the Oncologist Scale (TiOS-sf)(2 weeks)
- EORTC QLQ-OG25(3 months vs. baseline)
- Duration of consultation in minutes (min.)(through study completion, an average of 1 year)
- Health care providers' tailoring of treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- Treatment outcome category of health care providers' treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- Person initializing treatment outcome information measured with SOURCE observational scale(through study completion, an average of 1 year)
- Health care providers' (numerical) precision of treatment outcome information measured with SOURCE observational scale simulated patient consultations (effect intervention)(through study completion, an average of 1 year)
研究者
H.W.M. van Laarhoven
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)