NCT03965325Completed
FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 133 (actual)
- First submitted
- 3 May 2019
- Start date
- 7 Jun 2019
- Primary completion date
- 6 Jun 2022
- Lead sponsor
- IHU Strasbourg
- Diseases
- Colorectal cancer
- NCT number
- NCT03965325
What you commit to
- Study type: Observational
- Participants enrolled: 133
- From 7 Jun 2019 to the primary completion date, 6 Jun 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Psychiatric and cognitive impairment;
Other
- Pregnant or breastfeeding woman;
- Patient under juristic protection or under guardianship
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne, NHC Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.