Feasibility and first results of the trials-within-cohorts design in patients with lung cancer.
Mathijs Tomassen,
The Netherlands
PD-0669
Abstract
Feasibility and first results of the trials-within-cohorts design in patients with lung cancer.
Authors: Mathijs Tomassen1, Pim Damen1, Helena Verkooijen1, Max Peters2, Janneke van der Stap3, Anne van Lindert3, Joost Verhoeff1, Peter van Rossum1
1University Medical Center Utrecht, Radiotherapy, Utrecht, The Netherlands; 2University Medical Center, Utrecht, Utrecht, The Netherlands; 3University Medical Center Utrecht, Pulmonology, Utrecht, The Netherlands
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Purpose or Objective
‘Trials-within-Cohorts’
(TwiCs), previously referred to as ‘cohort multiple RCT’ is a modern trial
design that supports a quick and representative recruitment of patients for future
trials. To our knowledge, the ‘COhort for Lung cancer Outcome Reporting and
trial inclusion’ (COLOR) is the first TwiCs in patients with lung cancer. In
this study we aimed to assess the feasibility and first year results of COLOR.
Material and Methods
Since July 2020, all patients diagnosed with lung cancer referred
to the Radiotherapy department were eligible to participate in the ongoing prospective
COLOR study. At time of inclusion, written informed consent was requested for
use of patient data, regular in quality of life (QoL) questionnaires and
willingness to participate in future trials. After inclusion clinical baseline,
treatment, toxicity, follow-up, survival and QoL data were registered. To
assess QoL, validated questionnaires regarding global health, functional
scales, fatigue, anxiety, depression and work were sent out to participants at
predefined intervals (EORTC QLQ-C30, EORTC QLQ-LC13, EQ5D-5L, MFI, HADS and
WAI). To assess representativeness of the cohort, the EORTC QLQ-C30 functioning
scales of participants were compared with the published EORTC reference values.
Results
Of the 338 eligible patients between July 2020 and July 2021,
169 (50%) participated. Among 169 participants, 127 (75%) gave informed consent
to participate in the QoL questionnaires, of which 101 (80%) completed the
questionnaires at baseline, 81 (64%) after 1 month and 65 (51%) after 3 months.
Of all patients, 110 (65%) were willing to participate in future clinical
trials. At baseline, mean age was 68.4 years (+-9.2). Seventy-four patients (44%)
had stage I disease, 14 (9%) stage II, 52 (31%) stage III and 25 (14%) stage IV
(Table 1). The EORTC QLQ-C30 physical, role and cognitive functioning at
baseline were comparable with the EORTC QLQ-C30 reference values, whereas the
means of cognitive and emotional functioning were slightly higher in the COLOR study.
![](https://www.estro.org:443/ESTRO/media/Abstracts/188/c2ea0d13-5673-4cf9-a86b-a9811c397408.jpeg)
Conclusion
The TwiCs design appears feasible in patients with lung
cancer with fair participation and response rates. With a planned expansion to
other centers in the upcoming year, the COLOR study is expected to enable
multiple (randomized) evaluations of experimental interventions with important
advantages for recruitment, generalizability, and long-term outcome data
collection.