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

Lung Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529851
• Other study ID #: RHWJutland
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Regional Hospital West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer Stage IV
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of oncology, Regional Hospital West Jutland	Herning

Sponsors (3)

Lead Sponsor	Collaborator
Regional Hospital West Jutland	Danish Cancer Society, Danish Lung Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

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