The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up. Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.
This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption. All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years. By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
398
Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire
Overall survival
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months.
Progression free survival
First confirmed disease progression
Time frame: From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.
Performance status
Performance status will be evaluated according to the ECOG Perfomance Status Scale (Scale 0-5: 0 = fully active, able to carry on all pre-disease performance without restriction, 5=dead).
Time frame: At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.
Proportion of patients starting second-line anti-neoplastic treatment
Proportion of patients starting second-line anti-neoplastic treatment within 12 weeks from date of confirmed disease progression after randomization.
Time frame: Assessed up to 24 months.
Quality of life
Assessed by EORTC QLQ-C30-LC13 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. 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.
Time frame: At baseline and every three months, assessed up to 24 months.
Symptoms of depression
Assessed by the Patient Health Questionnaire (PHQ9). Score 0 (no symptoms) to 27 (severe symptoms).
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Time frame: At baseline and every three months, assessed up to 24 months.
Number of days of in-hospital care
Health care consumption will be assessed as number of days of in-hospital care during study participation.
Time frame: Assessed up to 24 months.