Viewing Study NCT05621902


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Study NCT ID: NCT05621902
Status: NOT_YET_RECRUITING
Last Update Posted: 2022-11-18
First Post: 2022-11-04
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
Sponsor: Mats Lambe
Organization:

Study Overview

Official Title: Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LUCA-S
Brief Summary: 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: 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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: