NCT05053997 Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients
| NCT ID | NCT05053997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2022-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 -
Contact & Investigator
Susanne O Dalton, Professor
PRINCIPAL INVESTIGATOR
Zealand University Hospital
Frequently Asked Questions
Who can join the NCT05053997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05053997 currently recruiting?
Yes, NCT05053997 is actively recruiting participants. Contact the research team at ril@cancer.dk for enrollment information.
Where is the NCT05053997 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Herning, Denmark, Odense, Denmark, Roskilde, Denmark and 2 additional locations.
Who is sponsoring the NCT05053997 clinical trial?
NCT05053997 is sponsored by Zealand University Hospital. The principal investigator is Susanne O Dalton, Professor at Zealand University Hospital. The trial plans to enroll 250 participants.
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