NAVIGATE - Improving Survival in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 overall survival among vulnerable lung cancer patients compared with standard care. Secondary outcomes include adherence to cancer treatment, symptom burden and health related quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Gødstrup Hospital
RECRUITING
Herning
Odense University Hospital
RECRUITING
Odense
Zealand University Hospital
RECRUITING
Roskilde
Sønderborg Sygehus
RECRUITING
Sønderborg
Vejle Sygehus
RECRUITING
Vejle
Contact Information
Primary
Rikke Langballe, PhD
ril@cancer.dk
+45 35 25 79 72
Backup
Randi V Karlsen, MEd
randi@cancer.dk
+45 35 25 76 65
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 518
Treatments
Experimental: NAVIGATE intervention arm
Nurse navigation
No_intervention: Navigate control arm
Standard treatment and care
Related Therapeutic Areas
Sponsors
Collaborators: Odense University Hospital, Hospital of Southern Jutland, Danish Cancer Society, Vejle Hospital
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov