Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Weekly symptom monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytology proven non-small cell lung cancer (NSCLC) NSCLC stage III or IV ≥ 18 years ECOG performance status 0- 2 Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis) Initial web-based application score of ≤ 6 Basic computer literacy Bank-ID (electronic identification system) and access to 1177 Vårdguiden The subject has given written consent to participate in the study Exclusion Criteria: Symptomatic brain metastases Pregnancy, breastfeeding, or planned pregnancy Persons under guardianship or deprived of liberty Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation Treatment or disease which, according to the investigator, can affect treatment or study results Ongoing participation in another interventional clinical study

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly symptom monitoring<br>Web-based weekly symptom monitoring in addition to standard follow-up | Other: Weekly symptom monitoring<br>* Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire<br>|
| No Intervention: Standard care<br>Standard follow-up according to guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | From date of randomization until the date of death from any cause, assessed up to 60 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | First confirmed disease progression | 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). | 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. | 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. | 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). | 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. | Assessed up to 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sweden