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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer Stage IV

Intervention / Treatment
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* Other: Weekly questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks. Access to internet connection Performance status ≤ 2 Patient has given his/her written informed consent Exclusion Criteria: Persons deprived of liberty or under guardianship or curators Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial.

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO intervention<br>Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period. | Other: Weekly questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 
| Inclusion rate | Number of included patients per screened patients Reasons for non-participation | 3 weeks | 
| Time usage per day on approval and handling alerts | Minutes spent per alert Minutes spent per telephone call | 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 | 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. | 3 weeks | 
| Alert-rate | Number of alerts sent to the hospital per questionnaires completed | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient reported outcomes, Symptom monitoring, Follow-up