Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
Half of patients with lung cancer face a limited life span of one-year survival, which is characterized by severe physical and psychological symptoms. Differences in stage, comorbidity but also treatment may explain a large proportion of the social inequality in lung cancer survival. Some vulnerable patients may not receive first line treatment as planned either due to poor performance status or if they are not able to adhere to treatment appointments. Knowing how to navigate the health system may be a barrier preventing vulnerable patients in receiving optimal treatment. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored program including systematic screening of symptoms using PROs and a physical training program will significantly improve a composite outcome of survival and quality of life as the primary outcome among vulnerable lung cancer patients compared with standard care. Secondary outcomes include adherence to cancer treatment, symptom burden and overall survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years of age
Diagnosed with NSCLC at all stages regardless of treatment intension at the participating departments
Performance status ≤ 2
Vulnerable according to pre-defined criteria
Disqualifiers
Severe untreated psychiatric disorder (e.g. psychosis) or cognitive problems (e.g. dementia) preventing informed consent
Not able to receive treatment
Not able to read and understand Danish -
Trial design
Design model
Parallel
Treatments tested in this trial
NAVIGATE
BehavioralPatients' symptoms are systematically monitored by use of bi-weekly patient reported outcomes and nurse navigators will initiate appropriate actions in terms of medical treatment or guidance of self-management strategies. Nurse navigators will motivate and support patients in health behavior changes and in selfmanaging their treatment and symptoms, and, if relevant, refer to existing rehabilitation services at the hospital or at the local rehabilitation center. Physiotherapists will supervise a training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: NAVIGATE intervention armExperimental treatment 1 intervention
Group B: Navigate control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
A hierarchical composite outcome of survival and global quality of life
Measured from death from all causes and the Global Health Status (a subscale of EORTC QLQ-C30)
Time frame
3 months from randomizationSecondary outcomes
1
Overall survival
Measured by death from all causes
Time frame
3 months from randomization2
Overall survival
Measured by death from all causes
Time frame
6 months from randomization3
Overall survival
Measured from death from all causes
Time frame
12 months from randomization4
Adherence to cancer treatment
Measured by date of skipped treatments or delays if any, and dose administered
Time frame
3 months from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Danish Cancer Society
Collaborator
Odense University Hospital
Collaborator
Vejle Hospital
Collaborator
Hospital of Southern Jutland
Collaborator
Source ClinicalTrials.gov