Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)

Study Overview
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Brief Summary
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Rationale: Lung cancer is the predominant cancer type worldwide in terms of incidence and mortality. Novel treatment techniques are continuously being developed, all of which need thorough evaluation before they can be implemented in clinical routine. The gold standard design for such evaluation is the randomized controlled trial (RCT), but this design has shown many challenges, particularly in the oncology setting. The 'Trials within Cohorts' (TwiCs) design, previously referred to as 'cohort multiple RCT' (cmRCT), is a promising design enabling multiple (simultaneous) randomized evaluations of experimental interventions, with advantages for recruitment, comparability, and long-term outcome data collection. This design will speed up the process of translating treatment innovations in daily clinical practice. Objective: 1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions. Study design: Observational, prospective cohort study, according to the 'TwiCs' design. Study population: All patients with lung cancer referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht. Main study parameters/endpoints: Clinical parameters (performance status, co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (toxicity, reintervention and survival), and patient-reported outcomes.

Detailed Description
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The basis of the TwiCs approach is an observational prospective cohort, consisting of patients with the same condition of interest, who undergo standard treatment. The patient characteristics are captured at baseline, and clinical and patient-reported outcome measures are captured at fixed time points. When a new intervention is ready for formal evaluation, eligible patients within the observational cohort are identified. From this so-called sub-cohort, patients will be randomly selected to undergo the new intervention. The other eligible patients will not be approached and undergo the standard treatment. Outcomes of the selected patients receiving the new intervention will be compared with the outcomes of the non-selected patients receiving the standard treatment. Within this cohort, the same process can be simultaneously repeated for other interventions. Advantages of the TwiCs design include ongoing information as to the natural history of the condition and to treatment as usual, the ability to facilitate multiple simultaneous randomized evaluations, the improved comparability between trials, and the patient-centered informed consent procedure. By setting up the prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), we aim to: Gather data on natural disease progression, treatment response, disease recurrence, complications, quality of life and survival of patients with lung cancer; Collect a patient group willing to participate in studies; Facilitate multiple, parallel randomized controlled trials within the cohort.

Official Title
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Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Radiographic and/or histologic proof of lung cancer; Referred to Department of Pulmonology or the Department of Radiotherapy for treatment. Exclusion Criteria: Mental disorder or cognitive dysfunction that hinders the patient's ability to understand the informed consent procedure and/or study details; Patients with severe psychiatric disorders; Inability to understand the Dutch language.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related Quality of Life | Assesment of Health-related quality of life in lung cancer patients undergoing treatment | Up to 10 years after treatment | 
| Occurence of toxicity (adverse events) | Grade ≥3 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). For 'dysphagia' and 'pneumonitis' endpoints, also grade 2 toxicity will be scored. | Up to 10 years after treatment | 
| Readmission | Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression. | Up to 10 years after treatment | 
| Survival | Date of last follow-up, date of local progression, date of distant progression, location of distant progression. Overall survival (Survival of participating patients will be recorded using the follow up questionnaires [returned by family members] or are derived from the Statistic Netherlands Database [in Dutch: Centraal Bureau voor de Statistiek, CBS] and Dutch Cancer Registry [in Dutch: Integraal Kankercentrum Nederland, IKNL]). | Up to 10 years after treatment |