Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05053997

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

NAVIGATE

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.

Primary outcomes

  1. A hierarchical composite outcome of survival and global quality of life

    Time frame: 3 months from randomization

    Measured from death from all causes and the Global Health Status (a subscale of EORTC QLQ-C30)

Secondary outcomes

  1. Overall survival

    Time frame: 3 months from randomization

    Measured by death from all causes

  2. Overall survival

    Time frame: 6 months from randomization

    Measured by death from all causes

  3. Overall survival

    Time frame: 12 months from randomization

    Measured from death from all causes

  4. Adherence to cancer treatment

    Time frame: 3 months from randomization

    Measured by date of skipped treatments or delays if any, and dose administered

  5. Adherence to cancer treatment

    Time frame: 6 months from randomization

    Measured by date of skipped treatments or delays if any, and dose administered

  6. Adherence to cancer treatment

    Time frame: 12 months from randomization

    Measured by date of skipped treatments or delays if any, and dose administered

  7. Symptom burden and health related quality of life

    Time frame: 3 months from randomization

    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.

  8. Symptom burden and health related quality of life

    Time frame: 6 months from randomization

    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.

  9. Symptom burden and health related quality of life

    Time frame: 12 months from randomization

    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.

  10. Quality of life (QOL) measured by EuroQol EQ-5D-5L

    Time frame: 3 months from randomization

    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.

  11. Quality of life (QOL) measured by EuroQol EQ-5D-5L

    Time frame: 6 months from randomization

    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. Quality of life (QOL) measured by EuroQol EQ-5D-5L

    Time frame: 12 months from randomization

    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.

  13. Health behavior

    Time frame: 3 months from randomization

    Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior

  14. Health behavior

    Time frame: 6 months from randomization

    Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.

  15. Health behavior

    Time frame: 12 months from randomization

    Measured by single-items questions related to physical activity, alcohol consumption and smoking behavior.

  16. Self-efficacy and self-activation

    Time frame: 3 months from randomization

    Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)

  17. Self-efficacy and self-activation

    Time frame: 6 months from randomization

    Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)

  18. Self-efficacy and self-activation

    Time frame: 12 months from randomization

    Measured by single items from Patient Activation Measure (PAM) and Health Education Impact Questionnaire (HEIQ)

  19. Rehabilitation services

    Time frame: 3 months from randomization

    Measured by single item question

  20. Rehabilitation services

    Time frame: 6 months from randomization

    Measured by single item question

  21. Rehabilitation services

    Time frame: 12 months from randomization

    Measured by single item question

  22. Process evaluation

    Time frame: 3 months from 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

  23. Process evaluation

    Time frame: 12 months from 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.

  24. Cost-effectiveness

    Time frame: 12 months from randomization

    Evaluation by health care costs and QALYs (Quality Adjusted Life Years) between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Randi V Karlsen, MEd

CONTACT

[email protected]

+45 35 25 76 65

Rikke Langballe, PhD

CONTACT

[email protected]

+45 35 25 79 72

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Danish Cancer Society
  • Hospital of Southern Jutland
  • Odense University Hospital
  • Vejle Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2021
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.