Lung Cancer Stage IV Clinical Trial
Official title:
Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.
This pilot study will test if the use of AmbuFlex (a generic on-line system for self-recorded
patient reported outcomes) is feasible for a following randomized trial (PRO-WIDE trial -
Patient Reported Outcomes used for Weekly Internet-based DEtection of progressive disease in
lung cancer; a randomized controlled trial). The RCT (randomized controlled trial) will test
if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase
survival in Danish lung cancer patients during follow-up or maintenance treatment. A
threshold mechanism will automatically send an alert to the hospital in case of alarming
symptoms and the patient will be contacted by the clinicians.
In the pilot study, initial interviews with 7-10 patients will explore possible missing items
and conceptual issues in the questionnaire. Based on the results an adjustment of the
questionnaire will be considered.
Then the system including the alert trigger mechanism will be tested on 20 patients in
medical antineoplastic treatment for three consecutive weeks. Acceptability, usability and
relevance will be evaluated by a questionnaire at the end of the study period.
Inclusion-rate, number of alerts per completed questionnaire and time usage of
alert-management will be registered. For final evaluation, interviews with two nurses and two
doctors will be made at the end of the study.
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