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

NCT ID: NCT05053997

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAVIGATE intervention arm

Nurse navigation

Group Type EXPERIMENTAL

NAVIGATE

Intervention Type 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 control arm

Standard treatment and care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Hospital of Southern Jutland

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susanne Dalton

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne O Dalton, Professor

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Pernille E Bidstrup, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Cancer Society

Erik Jakobsen, PhD

Role: PRINCIPAL_INVESTIGATOR

The Danish Lung Cancer Research Center

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Gødstrup Hospital

Herning, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Zealand University Hospital

Roskilde, , Denmark

Site Status RECRUITING

Sønderborg Sygehus

Sønderborg, , Denmark

Site Status RECRUITING

Vejle Sygehus

Vejle, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Rikke Langballe, PhD

Role: CONTACT

Phone: +45 35 25 79 72

Email: [email protected]

Randi V Karlsen, MEd

Role: CONTACT

Phone: +45 35 25 76 65

Email: [email protected]

Facility Contacts

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Tine Krogh Mcculloch

Role: primary

Hanne Linnet

Role: primary

Christian Borbjerg Laursen

Role: primary

Line Larsen

Role: backup

Mads Nordahl Svendsen

Role: primary

Kim Wedervang

Role: primary

Role: backup

Ole Hilberg

Role: primary

Kirsten Jones

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38123657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36316074 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NAVIGATE

Identifier Type: -

Identifier Source: org_study_id