Pilot Digital Follow-up of Lung Cancer

January 13, 2021 updated by: prof. dr. Wim Marneffe, Hasselt University

Pilot Study - Measurement of Cost, Outcome and Patient Experience of a Digital Weekly Follow up of Lung Cancer Patients

In the pilot study, 30 patients with metastatic lung cancer (stage IV) will be recruited at the start of their stage IV treatment from February 2019. The study period per patient will last six months, from the start of the stage IV treatment. Patients are eligible if they are diagnosed with stage IV lung cancer, speak sufficient Dutch, and are willing to participate. Patients are randomly assigned to two arms by simple randomization. In the intervention arm, 15 patients will receive a weekly questionnaire. Alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. In the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. The standard care pathways and the care team are the same in both groups. In this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients (n=5) and the care team (n=5), and workload registration of the care team during a six-month period for all included patients in the pilot.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • AZ Delta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stage IV lung cancer,
  • speak sufficient Dutch
  • willing to participate

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control arm
Experimental: intervention arm
In the intervention arm, 15 patients will receive a weekly questionnaire. Alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. In the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. The standard care pathways and the care team are the same in both groups. In this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients and the care team, and workload registration of the care team during a six-month period.
Device: Weekly digital follow up
weekly digital follow-up by sending a questionnaire to patients and sending alerts based on the questionnaire to the care team

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the response rates on the digital weekly questionnaire
Time Frame: up to 26 weeks
In the weekly digital questionnaire the patient reports adverse events and psychosocial support needs. Based on this questionnaire alerts are generated to the care team
up to 26 weeks
Assess the Response on the validation questionnaire at Baseline and at Week 26
Time Frame: up to 26 weeks
In the validation questionnaire the patient evaluates the online system, the relevance and difficulty of the questions
up to 26 weeks
Assess the workload of responding to the alerts on the weekly questionnaire for the care team
Time Frame: up to 26 weeks
the workload is assessed by daily registration of the workload (in minutes) per patient during the six-month registration period by the care team: 2 MD pulmonologists, oncology nurse, psychologist, palliative support, and dietician
up to 26 weeks
Assess the clinical utility of the alerts for the care team
Time Frame: month 6
In semi-structured interviews with the multidisciplinary care team, the clinical utility of receiving and responding to alerts is assessed with every care giver: an MD pulmonologist, oncology nurse, psychologist, palliative support, and dietician
month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Validation questionnaire
Time Frame: Baseline
Baseline
Validation questionnaire
Time Frame: month 6
month 6
Weekly questionnaire based on PRO CTC-AE
Time Frame: up to 26 weeks
As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days…
up to 26 weeks
EORTC QLQ-C30
Time Frame: Baseline
Questionnaire developed to assess the quality of life of cancer patients The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. No item occurs in more than one scale ( range in score from 0 to 100).
Baseline
EORTC QLQ-C30
Time Frame: week 6
Questionnaire developed to assess the quality of life of cancer patients The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. No item occurs in more than one scale ( range in score from 0 to 100).
week 6
EORTC QLQ-C30
Time Frame: week 12
Questionnaire developed to assess the quality of life of cancer patients The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. No item occurs in more than one scale ( range in score from 0 to 100).
week 12
EORTC QLQ-C30
Time Frame: week 18
Questionnaire developed to assess the quality of life of cancer patients The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. No item occurs in more than one scale ( range in score from 0 to 100).
week 18
EORTC QLQ-C30
Time Frame: week 24
Questionnaire developed to assess the quality of life of cancer patients The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. No item occurs in more than one scale ( range in score from 0 to 100).
week 24
QLQ-LC13
Time Frame: baseline
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30). Scale 1-4 (1 Not at all - 4 very much).
baseline
QLQ-LC13
Time Frame: week 6
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30). Scale 1-4 (1 Not at all - 4 very much).
week 6
QLQ-LC13
Time Frame: week 12
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30). Scale 1-4 (1 Not at all - 4 very much).
week 12
QLQ-LC13
Time Frame: week 18
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30). Scale 1-4 (1 Not at all - 4 very much).
week 18
QLQ-LC13
Time Frame: week 24
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30). Scale 1-4 (1 Not at all - 4 very much).
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AZ Delta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wim Marneffe, prof. dr., Hasselt University
  • Study Chair: Veerle Ross, dr., Hasselt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FU- Lung cancer - 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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