Clinical trial NCT03529851: Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients
Official title: Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Stage IV
Keywords: Patient reported outcomes
Symptom monitoring
Follow-up
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Lung Cancer Group
First posted: 2018-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility pilot study
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks.
2. Access to internet connection
3. Performance status ≤ 2
4. Patient has given his/her written informed consent

Exclusion Criteria:

1. Persons deprived of liberty or under guardianship or curators
2. 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.

Primary outcomes:
measure: Techincal feasibility, acceptability and usability of the PRO system for patients
timeFrame: 3 weeks
measure: Inclusion rate
timeFrame: 3 weeks
measure: Time usage per day on approval and handling alerts
timeFrame: 3 weeks
measure: Barriers for implementation of the PRO system according to the clinical staff
timeFrame: 3 weeks
measure: Exploration of possible missing items and conceptual issues in the questionnaire.
timeFrame: 3 weeks
measure: Alert-rate
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of oncology, Regional Hospital West Jutland
Study officials:
affiliation: Department of Oncology, Regional Hospital West Jutland
name: Rasmus Friis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friis RB, Hjollund NH, Mejdahl CT, Pappot H, Skuladottir H. Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study. BMJ Open. 2020 Jun 17;10(6):e035673. doi: 10.1136/bmjopen-2019-035673.