NCT03529851

Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients

Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Regional Hospital West Jutland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer Stage IV

Interventions

Type	Name	Description
OTHER	Weekly questionnaires	In case of alarming symptoms reported in the questionnaire, an alert is automatically sent to the hospital. The clinicians will contact the patient, confirm the symptoms and intervene according to standard practice.

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2018-05-18
• Last updated: 2018-08-29

Locations

1 site across 1 country: Denmark