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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529851
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Danish Cancer Society
Danish Lung Cancer Group
Information provided by (Responsible Party):
Rasmus Blechingberg Friis, Regional Hospital West Jutland

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Stage IV Other: Weekly questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Techincal feasibility, acceptability and usability of the PRO system for patients [ Time Frame: 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.

  2. Inclusion rate [ Time Frame: 3 weeks ]
    Number of included patients per screened patients Reasons for non-participation

  3. Time usage per day on approval and handling alerts [ Time Frame: 3 weeks ]
    Minutes spent per alert Minutes spent per telephone call

  4. Barriers for implementation of the PRO system according to the clinical staff [ Time Frame: 3 weeks ]
    Identified through interviews with 2 nurses and 2 MDs after the study period

  5. Exploration of possible missing items and conceptual issues in the questionnaire. [ Time Frame: 3 weeks ]
    Identified through interviews with 7-10 patients prior to the pilot study.

  6. Alert-rate [ Time Frame: 3 weeks ]
    Number of alerts sent to the hospital per questionnaires completed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529851


Locations
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Denmark
Department of oncology, Regional Hospital West Jutland
Herning, Denmark, 7400
Sponsors and Collaborators
Regional Hospital West Jutland
Danish Cancer Society
Danish Lung Cancer Group
Investigators
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Principal Investigator: Rasmus Friis, MD Department of Oncology, Regional Hospital West Jutland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rasmus Blechingberg Friis, MD, Principal Investigator, Regional Hospital West Jutland
ClinicalTrials.gov Identifier: NCT03529851    
Other Study ID Numbers: RHWJutland
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rasmus Blechingberg Friis, Regional Hospital West Jutland:
Patient reported outcomes
Symptom monitoring
Follow-up
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases