NCT03529851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

April 24, 2018

Last Update Submit

August 28, 2018

Conditions

Lung Cancer Stage IV

Keywords

Patient reported outcomesSymptom monitoringFollow-up

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

PRO intervention

EXPERIMENTAL

Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period.

Other: Weekly questionnaires

Interventions

Weekly questionnairesOTHER

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.

PRO intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of oncology, Regional Hospital West Jutland

Herning, 7400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32554725DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rasmus Friis, MD

    Department of Oncology, Regional Hospital West Jutland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Feasibility pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 18, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)