Clinical trial NCT05053997: Navigate - Improving Survival in Vulnerable Lung Cancer Patients
Official title: NAVIGATE - Improving Survival in Vulnerable Lung Cancer Patients Through Nurse Navigation, Symptom Monitoring and Exercise: Study Protocol for a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Odense University Hospital
name: Vejle Hospital
name: Hospital of Southern Jutland
First posted: 2021-09-23
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Detailed description: During an 18-month period, consecutive newly diagnosed (\< 1 week) lung cancer patients will be pre-screened for eligibility and invited to participate at departments of oncology or respiratory medicine in Denmark. Participants (N=518) will be randomized (1:1) to standard treatment plus the intervention (intervention group) or standard treatment (control group) and followed for 1 year. Patients randomized to the control group will receive standard treatment and care consisting of a nurse and a physician, who sees the patient at treatment schedules and during follow-up, i.e. every 3 months for the first 2 years and subsequently annually up to 5 years.

Data will be collected from the intervention and the control group at baseline within 2 week after diagnosis, and 3, 6 months and 12 months after diagnosis. Physical tests will be performed at baseline and after 3 and 6 months. Baseline physical tests will be allowed after randomization if patients have difficulties in attentending the physiotherapy department within 2 weeks after their diagnosis. Considering that participating patients are vulnerable with limited resources we will proactively support patients in responding to questionnaires electronically, on paper or via telephone as per patient's preference allowing evaluation of the secondary outcomes as well as covariates and mechanisms. The primary outcome and treatment factors will be obtained from the lung cancer clinical database and individual medical journals. In order to develop costutility analyses, information on use of health services will be retrieved from the national registers.

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 -

Primary outcomes:
measure: Overall survival
timeFrame: 12 months from randomization
Secondary outcomes:
measure: Overall survival
timeFrame: 3 months from randomization
measure: Overall survival
timeFrame: 6 months from randomization
measure: Adherence to cancer treatment
timeFrame: 3 months from randomization
measure: Adherence to cancer treatment
timeFrame: 6 months from randomization
measure: Adherence to cancer treatment
timeFrame: 12 months from randomization
measure: Symptom burden and health related quality of life
timeFrame: 3 months from randomization
measure: Symptom burden and health related quality of life
timeFrame: 6 months from randomization
measure: Symptom burden and health related quality of life
timeFrame: 12 months from randomization
measure: Quality of life (QOL) measured by EuroQol EQ-5D-5L
timeFrame: 3 months from randomization
measure: Quality of life (QOL) measured by EuroQol EQ-5D-5L
timeFrame: 6 months from randomization
measure: Quality of life (QOL) measured by EuroQol EQ-5D-5L
timeFrame: 12 months from randomization
measure: Health behavior
timeFrame: 3 months from randomization
measure: Health behavior
timeFrame: 6 months from randomization
measure: Health behavior
timeFrame: 12 months from randomization
measure: Self-efficacy and self-activation
timeFrame: 3 months from randomization
measure: Self-efficacy and self-activation
timeFrame: 6 months from randomization
measure: Self-efficacy and self-activation
timeFrame: 12 months from randomization
measure: Rehabilitation services
timeFrame: 3 months from randomization
measure: Rehabilitation services
timeFrame: 6 months from randomization
measure: Rehabilitation services
timeFrame: 12 months from randomization
measure: Process evaluation
timeFrame: 3 months from evaluation
measure: Process evaluation
timeFrame: 12 months from evaluation
measure: Cost-effectiveness
timeFrame: 12 months from randomization
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Herning
country: Denmark
facility: Gødstrup Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Sønderborg
country: Denmark
facility: Sønderborg Sygehus
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Zealand University Hospital
name: Susanne O Dalton, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Cancer Society
name: Pernille E Bidstrup, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Danish Lung Cancer Research Center
name: Erik Jakobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.