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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

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • 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.
  • Inclusion rate [ Time Frame: 3 weeks ]
    Number of included patients per screened patients Reasons for non-participation
  • Time usage per day on approval and handling alerts [ Time Frame: 3 weeks ]
    Minutes spent per alert Minutes spent per telephone call
  • 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
  • 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.
  • Alert-rate [ Time Frame: 3 weeks ]
    Number of alerts sent to the hospital per questionnaires completed
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • 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
  • Inclusion rate [ Time Frame: 3 weeks ]
    Number of included patients per screened patients Reasons for non-participation
  • Time usage per day on approval and handling alerts [ Time Frame: 3 weeks ]
    Minutes spent per alert Minutes spent per telephone call
  • 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
  • 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.
  • Alert-rate [ Time Frame: 3 weeks ]
    Number of alerts sent to the hospital per questionnaires completed
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients
Official Title  ICMJE Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility pilot study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Lung Cancer Stage IV
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: PRO intervention
Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period.
Intervention: Other: Weekly questionnaires
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
15
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529851
Other Study ID Numbers  ICMJE RHWJutland
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rasmus Blechingberg Friis, Regional Hospital West Jutland
Study Sponsor  ICMJE Regional Hospital West Jutland
Collaborators  ICMJE
  • Danish Cancer Society
  • Danish Lung Cancer Group
Investigators  ICMJE
Principal Investigator: Rasmus Friis, MD Department of Oncology, Regional Hospital West Jutland
PRS Account Regional Hospital West Jutland
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP