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

Regional Hospital West Jutland

Status: Completed

Conditions: Lung Cancer Stage IV

Treatments: Other: Weekly questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT03529851

RHWJutland

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PRO intervention

Experimental group

Description:

Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period.

Treatment:

Other: Weekly questionnaires