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FOcUs on Colorectal CAncer oUtcomes: Long-Term Study

NCT03965325 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 133

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Use of a standardized set to collect clinical and patient-centered data, to assess the trend of the Global Health Status overtime in colorectal cancer patients

Patients' data (baseline characteristics, clinical and PROMs outcomes) will be collected according to patient-centered standardized set regarding ICHOM recommendations. Data collection and the follow-up schedule are carried out at : baseline (before any treatment or surgery), 1- and 6-month follow-up and then once a year.

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Didier Mutter, MD, PhD · Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2022-06-06
Completion
2024-02-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965325 on ClinicalTrials.gov