Navigate - Improving Survival and Quality of Life in Vulnerable Lung Cancer Patients

NCT05053997 | Recruiting

• 1 other identifier: NAVIGATE
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

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.

Conditions

Lung Cancer

Outcome Measures

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)

  3 months from randomization

Secondary Outcomes (24)

• Overall survival

  3 months from randomization

• Overall survival

  6 months from randomization

• Overall survival

  12 months from randomization

• Adherence to cancer treatment

  3 months from randomization

• Adherence to cancer treatment

  6 months from randomization

Study Arms (2)

NAVIGATE intervention arm

EXPERIMENTAL

Nurse navigation

Behavioral: NAVIGATE

Navigate control arm

NO INTERVENTION

Standard treatment and care

Interventions

NAVIGATE BEHAVIORAL

Patients' 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.

NAVIGATE intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Hospital of Southern Jutland: collaborator
• Danish Cancer Society: collaborator
• Odense University Hospital: collaborator
• Vejle Hospital: collaborator
• Zealand University Hospital: lead

Study Sites (6)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Gødstrup Hospital

Herning, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Zealand University Hospital

Roskilde, Denmark

RECRUITING

Sønderborg Sygehus

Sønderborg, Denmark

RECRUITING

Vejle Sygehus

Vejle, Denmark

RECRUITING

Related Publications (2)

• Langballe 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 DERIVED

• Langballe 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 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Susanne O Dalton, Professor

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

• Pernille E Bidstrup, PhD

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

• Erik Jakobsen, PhD

  The Danish Lung Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rikke Langballe, PhD

CONTACT

+45 35 25 79 72; ril@cancer.dk

Randi V Karlsen, MEd

CONTACT

+45 35 25 76 65; randi@cancer.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 23, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)