FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Assess the most accurate trend of the Global Health Status (Quality of Life evolution) over time in colorectal cancer patients evaluated by the EORTC-QLQ-C30 questionnaire.
研究概览
简要总结
Colorectal cancer (CRC) affects men and women of all racial and ethnic groups and accounts for more than 600,000 deaths per year, globally. Current treatment options may involve surgery, chemotherapy (both adjuvant and neoadjuvant), radiation therapy, and palliative care, each with trade-offs between disease management and patients' quality of life. Unfortunately, significant disparity exists in the quality of care and there is a need for standardization to ensure high-value health care for all patients.
This study evaluates the introduction of a Value-Based Health Care (VBHC) patient-centered framework in CRC treatments. VBHC is an innovative approach that aims to improve health care by identifying and systematically measuring both medical and patient-reported health care outcomes and costs. By applying sets of disease-specific outcomes measurements, health care providers (HCP) can compare care strategies and make informed choices with regard to optimization of care, necessary investments and possible cost reductions.
The adoption of a VBHC patient-centered approach may have a significant impact on therapeutic areas constituting a major disease and cost burden for the global health care, such as CRC. It has the potential to improve cancer care planning, monitoring, and management of patients, by promoting better communication and shared decision making by patients and HCP.
A patient-reported outcome measurement (PROM) is defined as any report about a health condition and its treatment that comes directly from the patient. The use of a tailored pathway including PROMs improve both quality of life (QoL) and survival in cancer patients. Another essential requirement of VBHC approach is the outcome monitoring, to allow HCP accessing to evidence-based, simplified information on the hospital clinical practice and potentially increase health value for both patients and HCP. For patients with CRC, the International Consortium for Health Outcomes Measurement (ICHOM) developed a comprehensive patient-centered outcomes measurement set that could be used in the clinical practice to monitor patients' status.
The purpose of this study is to evaluate the introduction of a VBHC approach in CRC treatments, using a validated VBHC set of clinical outcomes and PROMs, to understand which practice would be most effective in achieving patient-centered care. The underlying hypothesis is that a periodic analysis of these outcomes could increase health value for both patients and HCPs.
详细描述
Colorectal cancer (CRC) affects men and women of all racial and ethnic groups and accounts for more than 600,000 deaths per year, globally. Current treatment options may involve surgery, chemotherapy (both adjuvant and neoadjuvant), radiation therapy, and palliative care, each with trade-offs between disease management and patients' quality of life. Unfortunately, significant disparity exists in the quality of care, and so outcomes delivered across institutions for each treatment modality, suggesting that unwarranted variation in the provision of care occurs for patients with CRC. Hence, there is a need for standardization to ensure high-value health care for all patients, regardless the hospital where they present.
This study evaluates the introduction of a Value-Based Health Care (VBHC) patient-centered framework in CRC treatments. VBHC is an innovative approach that aims to improve health care by identifying and systematically measuring both medical and patient-reported health care outcomes. By applying sets of disease-specific outcomes measurements, health care providers (HCP) can compare care strategies and make informed choices with regard to optimization of care, necessary investments and possible cost reductions. The need to move toward a more patient-centered approach has been highlighted to be crucial in the context of quality care. Patient-centered care is a key component of a health system that ensures that all patients have access to the outcomes that matter for them.
The adoption of a VBHC patient-centered approach may have a significant impact on therapeutic areas constituting a major disease and cost burden for the global health care, such as CRC. CRC causes significant morbidity and mortality, being the third most common cancer and the fourth most common cause of cancer deaths worldwide and the second most common cause of cancer deaths in Europe. The 5-years relative survival rate is 47% in Europe and 60% in the US. Moreover, the economic burden of CRC is expected to increase in the future, partly due to changing demographics and the introduction of new and resource-demanding treatments and screening methods. In this scenario, the introduction of VBHC-based clinical pathways has the potential to improve cancer care planning, monitoring, and management of patients, by promoting better communication and shared decision making by patients and healthcare providers.
Research Hypothesis In general, an essential requirement to be able to apply a VBHC approach is the clear definition of the disease-specific outcomes, both clinical and patient-reported. Clinical outcomes can be measured by activity data such as complication rates, type of surgery, re-hospitalization rates, or by agreed scales and other forms of measurement. A patient-reported outcome measurement (PROM) is defined as any report about a health condition and well-being (quality of life) that comes directly from the patient using a self-reported measure, without interpretation of the patient's response by a physician or anyone else.
PROMs are being advocated for use in routine clinical cancer practice and for the early detection of patient distress. The use of a tailored pathway including PROMs has been shown to improve both quality of life (QoL) and survival in cancer patients. The QoL, by assessing physical function and symptoms such as pain, and social functioning are known to be independent prognostic factors for overall survival of metastatic CRC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Confirmed CRC diagnosis not older than 8 years from the first treatment;
- •Age ≥18 years or minimum age as required by local regulations;
- •Ability and willingness to give written consent form ("Patient informed consent Form" or "Patient Data Release Authorization Form");
- •Ability and willingness to comply with the clinical investigational plan.
排除标准
- •Pregnant or breastfeeding woman;
- •Psychiatric and cognitive impairment;
- •Patient under juristic protection or under guardianship
结局指标
主要结局
Assess the most accurate trend of the Global Health Status (Quality of Life evolution) over time in colorectal cancer patients evaluated by the EORTC-QLQ-C30 questionnaire.
时间窗: Once a year, for maximum 3 years, from the second postoperative year
The EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. The global health status / Quality of Life scale runs from 1 (very poor) to 7 (excellent) and the others from 1 (not at all) to 4 (very much). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus: * a high score for a functional scale represents a high / healthy level of functioning, * a high score for the global health status / QoL represents a high QoL, * but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Assess the most accurate trend of the Global Health Status (Quality of Life evolution) over time in colorectal cancer patients evaluated by the EORTC-QLQ-C30 questionnaire.
时间窗: Baseline
The EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. The global health status / Quality of Life scale runs from 1 (very poor) to 7 (excellent) and the others from 1 (not at all) to 4 (very much). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus: * a high score for a functional scale represents a high / healthy level of functioning, * a high score for the global health status / QoL represents a high QoL, * but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Assess the most accurate trend of the Global Health Status (Quality of Life evolution) over time in colorectal cancer patients evaluated by the EORTC-QLQ-C30 questionnaire.
时间窗: Month 1 follow-up
The EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. The global health status / Quality of Life scale runs from 1 (very poor) to 7 (excellent) and the others from 1 (not at all) to 4 (very much). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus: * a high score for a functional scale represents a high / healthy level of functioning, * a high score for the global health status / QoL represents a high QoL, * but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Assess the most accurate trend of the Global Health Status (Quality of Life evolution) over time in colorectal cancer patients evaluated by the EORTC-QLQ-C30 questionnaire.
时间窗: Month 6 follow-up
The EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - C30) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. The global health status / Quality of Life scale runs from 1 (very poor) to 7 (excellent) and the others from 1 (not at all) to 4 (very much). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus: * a high score for a functional scale represents a high / healthy level of functioning, * a high score for the global health status / QoL represents a high QoL, * but a high score for a symptom scale / item represents a high level of symptomatology / problems.
次要结局
- Investigate predictors of clinical and PROMs outcomes in a real-life context(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the number of follow-up forms and their timelines(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the trend over time of the patient's baseline characteristics and outcomes regarding ICHOM (International Consortium for Health Outcomes Measurements) recommendations(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the proportion of patients involved in this study compared to the whole cohort of patients who have been treated for a colorectal cancer at Strasbourg's University Hospital(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the variation of clinical outcomes and PROMs(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the proportion of missing clinical outcomes and PROMs data collected using the standardized set developed by the ICHOM for CRC(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Evaluate qualitatively the impact of a VBHC approach on involved HCPs by collecting and analysing the annual interview responses from HCPs(Once a year, for maximum 3 years, from the second postoperative year)
- Measure healthcare costs during the study period(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the missing data pattern for each clinical outcomes and PROMs(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Evaluate the impact of a VBHC approach on patients(Once a year, for maximum 3 years, from the second postoperative year)
- Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-C30 questionnaire(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)
- Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-CR29 questionnaire(Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year)