Clinical trial · Interventional
Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients
NAVIGATE - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NAVIGATE | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NAVIGATE intervention arm
- description
- Nurse navigation
- interventionNames
- Behavioral: NAVIGATE
- type
- NO_INTERVENTION
- label
- Navigate control arm
- description
- Standard treatment and care
Primary outcomes (1)
- measure
- A hierarchical composite outcome of survival and global quality of life
- timeFrame
- 3 months from randomization
- description
- Measured from death from all causes and the Global Health Status (a subscale of EORTC QLQ-C30)
Secondary outcomes (24)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 -
References
Publications (2)
- DERIVEDLangballe R, Svendsen L, Jakobsen E, Dalton SO, Karlsen RV, Iachina M, Freund KM, Leclair A, Jorgensen LB, Skou ST, Ehlers JH, Torenholt R, Svendsen MN, Envold Bidstrup P. Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention. Sci Rep. 2023 Dec 20;13(1):22744. doi: 10.1038/s41598-023-50161-w. PMID 38123657
- DERIVEDLangballe R, Dalton SO, Jakobsen E, Karlsen RV, Iachina M, Freund KM, Leclair A, Nielsen AS, Andersen EAW, Rosthoj S, Jorgensen LB, Skou ST, Bidstrup PE. NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Oct 31;12(10):e060242. doi: 10.1136/bmjopen-2021-060242. PMID 36316074