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
- No intervention
N.a.
Outcome measures
Primary outcome
<p>Clinical parameters (performance status, co-morbidity, oncological history,<br />
symptoms, imaging, technical and treatment data), clinical endpoints (toxicity,<br />
reintervention and survival), and patient-reported outcomes.</p>
Secondary outcome
<p>Not applicable. </p>
Background summary
Lung cancer is the type of cancer that causes the highest number of deaths worldwide. In addition, the lung is one of the most common sites for metastases from primary tumors located elsewhere, such as colorectal cancer or melanoma.
New treatment techniques are continuously being developed and must be thoroughly evaluated before they can be implemented in clinical practice. Randomized controlled trials are the gold standard for such evaluations. However, conducting these trials in daily clinical practice presents significant challenges, particularly in an oncology population.
A promising design for multiple (simultaneous) randomized evaluations of experimental interventions—with potential benefits for recruitment, comparability, and long-term outcomes—is the “Trials within Cohorts” (TwiCs) design, formerly known as the cohort multiple randomized controlled trial (cmRCT).
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 patients with lung tumors. 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.
H. Tekatli
Heidelberglaan 100
Utrecht 3584 CA
Netherlands
0031887558800
imaging3@umcutrecht.nl
H. Tekatli
Heidelberglaan 100
Utrecht 3584 CA
Netherlands
0031887558800
imaging3@umcutrecht.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Age >= 18 years;
- Radiographic and/or histologic proof of lung tumor;
- Referred to 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.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
| Research portal | NL-008313 |