A COhort Study on Factors Leading to Vulnerability in Adult Patients With Serious Medical cOnditionS: the COSMOS-I Trial

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorTampere University Hospital

About this trial

The objective of this prospective multicentre study that recruits altogether 1500 older patients from the university hospitals of Tampere, Kuopio, and Oulu is to explore the clinical significance and detection of causes of generalized vulnerability. The objectives are:

O1 - Establish the prevalence of causes of generalized vulnerability among patients diagnosed with severe yet non-malignant diseases and local/locally advanced and advanced cancers, O2 - Study how causes of generalized vulnerability affect the time between the diagnosis and the adoption of a fully palliative treatment line, overall survival, and patient-reported quality of life in older adults severe diseases, and O3 - Evaluate how screening tools commonly used in patients without cancer perform in screening for causes of vulnerability in older adults with cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suspected or diagnosed disease

≥60 years old patients, except for patients receiving high-dose chemotherapy and stem cell transplantion who need to be ≥18 years old

Cross-sectional imaging maximum 45 days prior to consenting or before the next treatment line

Patients with cancer (other than patients with prostate cancer treated with hormonal treatment before radiation treatment): study procedures (excluding image analyses) must have been carried out maximum 1 month prior to the start of a new treatment line

Disqualifiers

Not willing or unable to give written consent

Patient not deemed suitable for the study by the researcher approaching the patient

Trial population

* Patients with local, locally advanced and metastatic prostate cancer (n=300) * Patients with locally advanced and metastatic lung cancer (n=300) * Patients with brain metastasis (n=300) * Patients with chronic subdural hematoma (n=300) * Patients receiving high-dose chemotherapy and stem cell transplantion

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Test set to determine vulnerability

    Other intervention

    This is a prospective observational study.

Treatment groups

2,050 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Prostate Cancer1 intervention
Group B: Lung Cancer1 intervention
Group C: Pelvic Fracture1 intervention
Group D: Chronic Subdural Hematoma1 intervention
Group E: Brain Metastasis1 intervention
Group F: High-dose Chemotherapy and Stem Cell Transplant1 intervention

Trial outcomes

Primary outcomes

1

Detected cause of vulnerability

Time frame
Around the time of study procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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