Clinical trial NCT03965325: FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
Official title: FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Value-Based Health Care
VBHC
Patient reported outcomes measure
PROMs
PROs
Colorectal Cancer
Patient reported outcomes
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with a CRC who had a surgical consultation, and who meet the inclusion/exclusion criteria are intended to participate in this study. Subject enrollment will continue for the whole study duration. The eligibility criteria are kept comprehensive to all CRC types to reflect centers routine clinical practice ("all-comer" or "real world" subjects). To avoid subject selection bias, consecutive screening and enrollment will be requested.

Brief summary: 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.

Detailed description: 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.

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 HCPs. It has been demonstrated that facilitation of data interpretation can improve medical care quality. In particular, a Dutch nationwide study showed that, by providing continuous feedback of benchmarked performance information to colorectal surgeons, clinical outcomes of patients undergoing colorectal cancer surgery improves and cost decreases.

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. Therefore, an exploratory study collecting ICHOM set of data could provide useful information to evaluate the feasibility, benefits and barriers of a VBHC approach for CRC.

The purpose of this study is then 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. The study will first explore the most accurate feasible trend of the Global Health Status (Quality of Life evolution) of patients but also clinical outcomes and other PROMs trends over time, the cause(s) of these trends, and whether any outcomes' predictors can be found. Furthermore, a general assessment of the impact of the VBHC approach on CRC treatments will be performed, in terms of general satisfaction and knowledge in medical care. Finally, cost associated with performed procedures and complications will be estimated ambispectively using the Time-driven Activity-based Costing (TDABC) methodology, where applicable. Additional participating sites shall be free to apply the same methodology or to measure costs derived from traditional hospital cost accounting systems.

Eligibility criteria: Inclusion Criteria:

1. Confirmed CRC diagnosis not older than 8 years from the first treatment;
2. Age ≥18 years or minimum age as required by local regulations;
3. Ability and willingness to give written consent form ("Patient informed consent Form" or "Patient Data Release Authorization Form");
4. Ability and willingness to comply with the clinical investigational plan.

Exclusion Criteria:

1. Pregnant or breastfeeding woman;
2. Psychiatric and cognitive impairment;
3. Patient under juristic protection or under guardianship

Primary outcomes:
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Month 1 follow-up
measure: 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.
timeFrame: Month 6 follow-up
measure: 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.
timeFrame: Once a year, for maximum 3 years, from the second postoperative year
Secondary outcomes:
measure: Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-C30 questionnaire
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-CR29 questionnaire
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the trend over time of the patient's baseline characteristics and outcomes regarding ICHOM (International Consortium for Health Outcomes Measurements) recommendations
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the proportion of missing clinical outcomes and PROMs data collected using the standardized set developed by the ICHOM for CRC
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: 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
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the number of follow-up forms and their timelines
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the missing data pattern for each clinical outcomes and PROMs
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Investigate predictors of clinical and PROMs outcomes in a real-life context
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Assess the variation of clinical outcomes and PROMs
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
measure: Evaluate the impact of a VBHC approach on patients
timeFrame: Once a year, for maximum 3 years, from the second postoperative year
measure: Evaluate qualitatively the impact of a VBHC approach on involved HCPs by collecting and analysing the annual interview responses from HCPs
timeFrame: Once a year, for maximum 3 years, from the second postoperative year
measure: Measure healthcare costs during the study period
timeFrame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
name: Didier Mutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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