FOcUs on Colorectal CAncer oUtcomes: Long-Term Study

NCT03965325 | Completed

• 1 other identifier: 19-001
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Value-Based Health Care; VBHC; Patient reported outcomes measure; PROMs; PROs; Colorectal Cancer; Patient reported outcomes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Baseline

• 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.

  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.

  Month 1 follow-up

• 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.

  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.

  Month 6 follow-up

• 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.

  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.

  Once a year, for maximum 3 years, from the second postoperative year

Secondary Outcomes (12)

• 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

• 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 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

• 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

Interventions

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 OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding woman;
• Psychiatric and cognitive impairment;
• Patient under juristic protection or under guardianship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67 091, France

Location

Related Publications (17)

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Related Links

• ICHOM Colorectal cancer data collection reference guide
• International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Didier Mutter, MD, PhD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 29, 2019
• Study Start: June 7, 2019
• Primary Completion: June 6, 2022
• Study Completion: February 8, 2024
• Last Updated: April 17, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)