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

Sponsor
Regional Hospital West Jutland (Other)
Overall Status
Completed
CT.gov ID
NCT03529851
Collaborator
Danish Cancer Society (Other), Danish Lung Cancer Group (Other)
20
Enrollment
1
Location
1
Arm
3
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Weekly questionnaires
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Feasibility pilot studyFeasibility 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 :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Inclusion rate [3 weeks]

    Number of included patients per screened patients Reasons for non-participation

  3. Time usage per day on approval and handling alerts [3 weeks]

    Minutes spent per alert Minutes spent per telephone call

  4. 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

  5. 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.

  6. Alert-rate [3 weeks]

    Number of alerts sent to the hospital per questionnaires completed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Rasmus Friis, MD, Department of Oncology, Regional Hospital West Jutland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Aug 29, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rasmus Blechingberg Friis, MD, Principal Investigator, Regional Hospital West Jutland
Patient reported outcomes
Symptom monitoring
Follow-up
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Aug 29, 2018