Lung Cancer Stage IV
Conditions
Keywords
Patient reported outcomes, Symptom monitoring, Follow-up
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.
Interventions
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.
Sponsors
Danish Cancer Society
Danish Lung Cancer Group
Regional Hospital West Jutland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Techincal feasibility, acceptability and usability of the PRO system for patients | 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 | 3 weeks | Number of included patients per screened patients Reasons for non-participation |
| Time usage per day on approval and handling alerts | 3 weeks | Minutes spent per alert Minutes spent per telephone call |
| Barriers for implementation of the PRO system according to the clinical staff | 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. | 3 weeks | Identified through interviews with 7-10 patients prior to the pilot study. |
| Alert-rate | 3 weeks | Number of alerts sent to the hospital per questionnaires completed |
Countries
Denmark
Outcome results
None listed