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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
Department of oncology, Regional Hospital West Jutland
Herning, Denmark
Techincal feasibility, acceptability and usability of the PRO system for patients
Measured by an evaluation questionnaire at the end of the pilot study categorized according to the specified topics with 5 response items for each question. All responses will be presented in a comprehensive chart.
Time frame: 3 weeks
Inclusion rate
Number of included patients per screened patients Reasons for non-participation
Time frame: 3 weeks
Time usage per day on approval and handling alerts
Minutes spent per alert Minutes spent per telephone call
Time frame: 3 weeks
Barriers for implementation of the PRO system according to the clinical staff
Identified through interviews with 2 nurses and 2 MDs after the study period
Time frame: 3 weeks
Exploration of possible missing items and conceptual issues in the questionnaire.
Identified through interviews with 7-10 patients prior to the pilot study.
Time frame: 3 weeks
Alert-rate
Number of alerts sent to the hospital per questionnaires completed
Time frame: 3 weeks
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