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.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters (performance status, co-morbidity, oncological history,
symptoms, imaging, technical and treatment data), clinical endpoints (toxicity,
reintervention and survival), and patient-reported outcomes.
Secondary outcome
Not applicable.
Background summary
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.
Study 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 burden and risks
Patients will not experience direct benefit from participation in the U-COLOR
cohort. By participating, patients will contribute to the evidence on clinical
factors associated with treatment outcome, quality of life (QoL) and survival.
This will lead to better and more personalized care for future lung cancer
patients. When not participating in RCTs, patients will receive the regular
optimal clinical care. Risks associated with participating in the U-COLOR
cohort study are negligible since it is an observational study. Filling out the
questionnaires entails the only potential burden for the patients participating
in this cohort. It will take approximately 20 minutes to fill out the
questionnaires each time.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years;
- Radiographic and/or histologic proof of lung cancer;
- Referred to the Department of Pulmonology or 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71047.041.19 |