Navigate - Improving Survival in Vulnerable Lung Cancer Patients

Study Overview
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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 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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: NAVIGATE


Participation Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVIGATE intervention arm<br>Nurse navigation | Behavioral: NAVIGATE<br>* 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.<br>|
| No Intervention: Navigate control arm<br>Standard treatment and care | |

What is the study measuring?
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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 |