Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03529851|
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Stage IV||Other: Weekly questionnaires||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Feasibility pilot study|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Experimental: PRO intervention
Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period.
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.
- Techincal feasibility, acceptability and usability of the PRO system for patients [ Time Frame: 3 weeks ]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.
- Inclusion rate [ Time Frame: 3 weeks ]Number of included patients per screened patients Reasons for non-participation
- Time usage per day on approval and handling alerts [ Time Frame: 3 weeks ]Minutes spent per alert Minutes spent per telephone call
- Barriers for implementation of the PRO system according to the clinical staff [ Time Frame: 3 weeks ]Identified through interviews with 2 nurses and 2 MDs after the study period
- Exploration of possible missing items and conceptual issues in the questionnaire. [ Time Frame: 3 weeks ]Identified through interviews with 7-10 patients prior to the pilot study.
- Alert-rate [ Time Frame: 3 weeks ]Number of alerts sent to the hospital per questionnaires completed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529851
|Department of oncology, Regional Hospital West Jutland|
|Herning, Denmark, 7400|
|Principal Investigator:||Rasmus Friis, MD||Department of Oncology, Regional Hospital West Jutland|