Navigate - Improving Survival in Vulnerable Lung Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: NAVIGATE

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.

• Study Type: Interventional
• Enrollment (Estimated): 518
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rikke Langballe, PhD; Phone Number: +45 35 25 79 72; Email: ril@cancer.dk
• Study Contact Backup: Name: Randi V Karlsen, MEd; Phone Number: +45 35 25 76 65; Email: randi@cancer.dk

Study Locations

• Denmark
  • Herning, Denmark
    • Recruiting
    • Gødstrup Hospital
    • Contact: Hanne Linnet; Email: hansin@rm.dk
  • Odense, Denmark
    • Recruiting
    • Odense University Hospital
    • Contact: Christian Borbjerg Laursen; Email: Christian.B.Laursen@rsyd.dk
    • Contact: Line Larsen; Email: Line.Larsen2@rsyd.dk
  • Roskilde, Denmark
    • Recruiting
    • Zealand University Hospital
    • Contact: Mads Nordahl Svendsen; Email: mnsv@regionsjaelland.dk
  • Sønderborg, Denmark
    • Recruiting
    • Sønderborg Sygehus
    • Contact: Kim Wedervang
    • Contact: Email: Kim.Wedervang@rsyd.dk
  • Vejle, Denmark
    • Recruiting
    • Vejle Sygehus
    • Contact: Ole Hilberg; Email: Ole.Hilberg@rsyd.dk
    • Contact: Kirsten Jones; Email: Kirsten.Jones@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAVIGATE intervention arm; Nurse navigation	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 training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes.
No Intervention: Navigate control arm; Standard treatment and care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Measured from death from all causes	12 months from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Measured by death from all causes	3 months from randomization
Overall survival	Measured by death from all causes	6 months from randomization
Adherence to cancer treatment	Measured by date of skipped treatments or delays if any, and dose administered	3 months from randomization
Adherence to cancer treatment	Measured by date of skipped treatments or delays if any, and dose administered	6 months from randomization
Adherence to cancer treatment	Measured by date of skipped treatments or delays if any, and dose administered	12 months from randomization
Symptom burden and health related quality of life	Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13). The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items. The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss,neuropathy, sore mouth and dysphagia). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	3 months from randomization
Symptom burden and health related quality of life	Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13). The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items. The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss, neuropathy, sore mouth and dysphagia). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	6 months from randomization
Symptom burden and health related quality of life	Measured by EORTC Questionnaire Core 30 (QLQ-C30) and the lung module (QLQ-LC13). The QLQ-C30 questionnaire consists of 30 questions with five functional scales (physical, role, cognitive, emotional and social), three symptom scales, a global health status / QoL scale, and six single items. The QLQ-LC13 module comprises both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (hair loss,neuropathy, sore mouth and dysphagia). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	12 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L	EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.	3 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L	EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.	6 months from randomization
Quality of life (QOL) measured by EuroQol EQ-5D-5L	EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.	12 months from randomization
Health behavior	Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior	3 months from randomization
Health behavior	Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.	6 months from randomization
Health behavior	Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.	12 months from randomization
Self-efficacy and self-activation	Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)	3 months from randomization
Self-efficacy and self-activation	Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)	6 months from randomization
Self-efficacy and self-activation	Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)	12 months from randomization
Rehabilitation services	Measured by single item question	3 months from randomization
Rehabilitation services	Measured by single item question	6 months from randomization
Rehabilitation services	Measured by single item question	12 months from randomization
Process evaluation	Evaluation by participant-observations during training and patient sessions with subsequent qualitative semi-structured interviews with participants about their experience of the intervention components; however, only among participants who provide informed consent for this. Focus group interviews with nurse navigators and physiotherapists will be conducted about their perceptions of the intervention (facilitators and barriers). Additionally, evaluation of intervention components will be measured using quantitative single-items questions	3 months from evaluation
Process evaluation	Evaluation by participant-observations during training and patient sessions with subsequent qualitative semi-structured interviews with participants about their experience of the intervention components; however, only among participants who provide informed consent for this. Focus group interviews with nurse navigators and physiotherapists will be conducted about their perceptions of the intervention (facilitators and barriers). Additionally, evaluation of intervention components will be measured using quantitative single-items questions.	12 months from evaluation
Cost-effectiveness	Evaluation by health care costs and QALYs (Quality Adjusted Life Years) between the two groups.	12 months from randomization

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Odense University Hospital; Danish Cancer Society; Vejle Hospital; Hospital of Southern Jutland
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NAVIGATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No