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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer Stage IV
• Intervention / Treatment: Other: Weekly questionnaires

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Department of oncology, Regional Hospital West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regional Hospital West Jutland
• Collaborators: Danish Cancer Society; Danish Lung Cancer Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Follow-up; Symptom monitoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RHWJutland

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No