NCT03965325: Foucault

FOcUs on Colorectal CAncer oUtcomes: Long-Term Study

Completed Last updated 17 April 2026

What this trial tests

trial testing 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 in Colorectal Cancer in 133 participants. Completed in 8 February 2024.

Timeline

7 June 2019

Primary endpoint
6 June 2022

8 February 2024

Quick facts

Lead sponsor	IHU Strasbourg
Status	Completed
Study type	OBSERVATIONAL
Enrollment	133
Start date	7 June 2019
Primary completion	6 June 2022
Estimated completion	8 February 2024
Sites	1 location across France

Drugs / interventions tested

• 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

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

IHU Strasbourg — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.