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Completed

NCT Number: NCT03529851

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

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.

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Key information

Conditions

Lung Cancer Stage IV Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of oncology, Regional Hospital West Jutland

Herning, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks.
  • Access to internet connection
  • Performance status ≤ 2
  • Patient has given his/her written informed consent

Exclusion criteria

  • Persons deprived of liberty or under guardianship or curators
  • 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.

Treatment and study plan

Weekly questionnaires

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Regional Hospital West Jutland

Other

Collaborators

  • Danish Cancer Society
  • Danish Lung Cancer Group

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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