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FOcUs on Colorectal CAncer oUtcomes: Long-Term Study (Foucault)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965325
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

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.


Condition or disease Intervention/treatment
Colorectal Cancer 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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline ]

    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.

  2. 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. [ Time Frame: Month 1 follow-up ]

    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.

  3. 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. [ Time Frame: Month 6 follow-up ]

    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.

  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. [ Time Frame: Once a year, for maximum 3 years, from the second postoperative year ]

    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.


Secondary Outcome Measures :
  1. Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-C30 questionnaire [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]

    The EORTC-QLQ-C30 questionnaire is composed of both multi-item scales and single-item measures:

    • the global health status score (Quality of Life), runs from 1 (very poor) to 7 (excellent);
    • the functional scores (Physical function, Emotional function, Anxiety…), runs from 1 (not at all) to 4 (very much).

    The trend of each category of PROMS given by the EORTC-QLQ-C30 will be evaluated in four groups of patients: tumor on the right and transverse part of the colon; tumor on the left part of the colon; rectal tumor; metastatic colorectal cancer.


  2. Assess the trend of all VBHC outcomes (baseline characteristics, clinical and PROMs outcomes) over time in CRC patients by the EORTC-QLQ-CR29 questionnaire [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]

    The symptom scores (Fatigue, Nausea and vomiting, Pain …), running from 1 (not at all) to 4 (very much), and given by EORTC (European Organisation for Research and Treatment of Cancer) will be evaluated by the use of the EORTC-QLQ-CR29 questionnaire.

    The trend of each category of PROMS given by the EORTC-QLQ-CR29 in four groups of patients: tumor on the right and transverse part of the colon; tumor on the left part of the colon; rectal tumor; metastatic colorectal cancer.


  3. Assess the trend over time of the patient's baseline characteristics and outcomes regarding ICHOM (International Consortium for Health Outcomes Measurements) recommendations [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]

    Trend over time will be analysed by means of Generalized Estimating Equation models as appropriate to account for repeated measures using patient as the subject. Baseline characteristics and outcomes will be assessed regarding ICHOM recommendations:

    • descriptive analysis of baseline characteristics (patients' demographic-, clinical-, tumor- and treatment factors, and treatment variables)
    • descriptive analysis of care status disutility (short-term treatment complications)
    • evaluation of the degree of health (Quality of Life, functioning, and long-term adverse effects) : from 1 (very poor) to 7 (excellent)
    • evaluation of the survival and disease control (number of overall survival, disease-specific survival, recurrence, and progression-free survival)
    • descriptive analysis of the quality of death (quality of end of life care (last 30 days of life))
    • evaluation of the symptoms score using EORTC-QLQ-C30 and CR29: from 1 (not at all) to 4 (very much)

  4. Assess the proportion of missing clinical outcomes and PROMs data collected using the standardized set developed by the ICHOM for CRC [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    The average number of missing clinical outcomes and PROMs data collected using the standardized set developed by the ICHOM for CRC at each follow-up visit will be calculated and used to determine the level of relevance and confidence for each variable

  5. 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 [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    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 and the proportion of patient who refused to participate to the study.

  6. Assess the number of follow-up forms and their timelines [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    The number of follow-up forms and their timelines, by patient

  7. Assess the missing data pattern for each clinical outcomes and PROMs [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    The outcomes and PROMs will be classified into the three main classes of missing pattern, i.e. univariate, monotone, and arbitrary, to select actions for future data collection

  8. Investigate predictors of clinical and PROMs outcomes in a real-life context [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    Predictors of clinical outcomes and PROMs will be investigated by performing univariate and multivariate statistical analysis, when appropriate

  9. Assess the variation of clinical outcomes and PROMs [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]

    Control charts will be used to monitor clinical outcomes and PROMs in both Variable data charts as individual, average and range charts and Combination Charts (x-bar standard deviation, process capability, etc.).

    Control charts will have the following features:

    • Data points could be averages of subgroup or individual measurements plotted on the x and y axis and joined by a line. Time is always on the x-axis.
    • The Average or Center Line is the average or mean of the data points and is drawn across the middle section of the graph.
    • The Upper Control Limit (UCL) is drawn above the centerline. This is equal to 3 or 2 times of the standard deviation line.
    • The Lower Control Limit (LCL) is drawn below the centerline. This is equal to 3 or 2 times of the standard deviation line.

  10. Evaluate the impact of a VBHC approach on patients [ Time Frame: Once a year, for maximum 3 years, from the second postoperative year ]
    The impact of a VBHC approach on patient will be qualitatively evaluated by collecting and analysing the annual survey responses from patients on their perception and satisfaction of a VBHC approach: scale from "very satisfied" to "not satisfied".

  11. Evaluate qualitatively the impact of a VBHC approach on involved HCPs by collecting and analysing the annual interview responses from HCPs [ Time Frame: Once a year, for maximum 3 years, from the second postoperative year ]
    The impact of a VBHC approach on HCPs will be qualitatively evaluated by collecting and analysing the annual interview responses from HCPs concerning the satisfaction (scale from "very satisfied" to "not satisfied"), the introduction of new recommendations during the follow-up period (e.g., addition or deletion of a specific follow-up visit) and knowledge in clinical practice (e.g., inclusion of pain specialists or psychologists). Survey data will be reported using summary statistics and supporting graphical representations.

  12. Measure healthcare costs during the study period [ Time Frame: Baseline; Month 1 follow-up; Month 6 follow-up; Once a year, for maximum 3 years, from the second postoperative year ]
    At the hepato-digestive pole, Strasbourg's University Hospital, healthcare costs will be measured by applying the Time-driven Activity-based Costing (TDABC) methodology. Other eventual additional participating sites will be free to apply the same methodology or to measure costs derived from traditional hospital cost accounting systems. An assessment of the outcomes of the two different approaches could be made between different methodologies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965325


Contacts
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Contact: Armelle Takeda, PhD +33(0)390413608 armelle.takeda@ihu-strasbourg.eu

Locations
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France
Service de Chirurgie Digestive et Endocrinienne, NHC Recruiting
Strasbourg, France, 67 091
Contact: Didier Mutter, MD, PhD    +33(0)3 69 55 05 53    didier.mutter@chru-strasbourg.fr   
Sponsors and Collaborators
IHU Strasbourg
Investigators
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Principal Investigator: Didier Mutter, MD, PhD Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
Additional Information:
Publications:

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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT03965325    
Other Study ID Numbers: 19-001
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
Value-Based Health Care
VBHC
Patient reported outcomes measure
PROMs
PROs
Colorectal Cancer
Patient reported outcomes
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases