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

Official title

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

Overview

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.

Detailed description

During a period of 3 years and 10 months, 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=250) 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 6 weeks 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 attending the physiotherapy department within 6 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 primary and secondary outcomes as well as covariates and mechanisms. The treatment factors will be obtained from the lung cancer clinical database and individual medical journals. In order to develop cost utility analyses, information on use of health services will be retrieved from the national registers.

Interventions

• Behavioral NAVIGATE
  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

Primary outcome measures

• A hierarchical composite outcome of survival and global quality of life [Time frame: 3 months from randomization]

Secondary outcome measures (12)

• Overall survival [Time frame: 3 months from randomization]
• Overall survival [Time frame: 6 months from randomization]
• Overall survival [Time frame: 12 months from randomization]
• Adherence to cancer treatment [Time frame: 3 months from randomization]
• Adherence to cancer treatment [Time frame: 6 months from randomization]
• Adherence to cancer treatment [Time frame: 12 months from randomization]
• Symptom burden and health related quality of life [Time frame: 3 months from randomization]
• Symptom burden and health related quality of life [Time frame: 6 months from randomization]
• Symptom burden and health related quality of life [Time frame: 12 months from randomization]
• Quality of life (QOL) measured by EuroQol EQ-5D-5L [Time frame: 3 months from randomization]
• Quality of life (QOL) measured by EuroQol EQ-5D-5L [Time frame: 6 months from randomization]
• Quality of life (QOL) measured by EuroQol EQ-5D-5L [Time frame: 12 months from randomization]

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 6 centers

• Aalborg University Hospital — Aalborg
• Gødstrup Hospital — Herning
• Odense University Hospital — Odense
• Zealand University Hospital — Roskilde
• Sønderborg Sygehus — Sønderborg
• Vejle Sygehus — Vejle

Publications

• 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
• 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/bmjo PMID 36316074

Identifiers

NCT: NCT05053997 · NAVIGATE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗