Standard of Care Lifestyle Support for Stage III NSCLC Patients

Maastricht Radiation Oncology

Overview

Offering an early-initiated supportive care program to stage III NSCLC patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well as the patients receiving 12 months of durvalumab.

In inoperable Stage III Non-Small Cell Lung Cancer (NSCLC), consolidation immune checkpoint inhibition with the PD-L1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum-based chemoradiotherapy (CCRT) for 12 months results in remarkable improvement of 3-year overall survival rates (57% vs 43.5%). This tri-modal therapy has become the new standard of care. Unfortunately, the tri-modal therapy frequently causes adverse events such as fatigue and, to a much lesser degree, cough, dyspnea and pneumonitis, resulting in treatment cessation in 15% - 53% of the patients (15%) (53%). For the most optimal overall survival (OS) and disease-free survival (DFS), compliance to the full treatment regimen, i.e. in the ideal situation 100% of patients completing their full course of CCRT and receiving durvalumab for one year, is expected to have significant and relevant beneficial effects. Optimizing patients' fitness is essential in order to handle the tough full treatment regimen.

Study Type

OBSERVATIONAL

Conditions

Non Small Cell Lung Cancer

Interventions

Lifestyle adviceBEHAVIORAL

Patients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC * Participant is willing and able to give informed consent for participation in the trial * Aged 18 years or above * Scheduled to receive one of the following two therapeutic strategies: * Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC * Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC * Able and willing to comply with all trial requirements Exclusion Criteria: * Mixed non-small cell lung cancer with other histology such as small cell lung cancer * Not able to comply with the study protocol * Less than 18 years old * Pregnancy or not able to comply with adequate contraception in women with child baring potential * Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer * Previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened) * Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study

Outcomes

Primary Outcomes

Compliance

Compliance to CCRT and durvalumab treatment

Time frame: 12 months

Secondary Outcomes

Percentage adhering advice

Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice

Time frame: 12 months

Perctenage use of watch

Improving standard of care lifestyle support by measuring % use of the watch (and app)

Time frame: 12 months

Percentage dysphagia

Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia

Time frame: 12 months

Percentage dyspnea

Improving standard of care lifestyle support by measuring % grade 2 dyspnea

Time frame: 12 months

Percentage hospitalization

Improving standard of care lifestyle support by measuring % hospitalization for (treatment-related) complications + specification (from start until 6 weeks after radiotherapy)

Time frame: 12 months

Standard of care lifestyle support

Measuring match between lifestyle advice and personal circumstances by questionnaire

Time frame: 12 months

Barriers

Measuring adherence of barriers and facilitators in lifestyle support by questionnaire

Data from ClinicalTrials.gov

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