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Lung CancerNCT04712149

Pilot Digital Follow-up of Lung Cancer

A study testing Weekly digital follow up in people with Lung Cancer, run by Hasselt University at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Weekly digital follow up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBelgium
Study dates
1 Feb 2019to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

About this study

Official title: 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.

Conditions
Lung Cancer
Being tested
Weekly digital follow up
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weekly digital follow upDevice

    weekly digital follow-up by sending a questionnaire to patients and sending alerts based on the questionnaire to the care team

Study groups in NCT04712149
Study groupRoleWhat they receive
intervention armExperimentalIn 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.
Receives: Device: Weekly digital follow up
Control armNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the response rates on the digital weekly questionnaire

    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

    Measured: up to 26 weeks

  2. Assess the Response on the validation questionnaire at Baseline and at Week 26

    In the validation questionnaire the patient evaluates the online system, the relevance and difficulty of the questions

    Measured: up to 26 weeks

  3. Assess the workload of responding to the alerts on the weekly questionnaire for the care team

    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

    Measured: up to 26 weeks

  4. Assess the clinical utility of the alerts for the care team

    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

    Measured: month 6

Secondary outcomes (13)

  1. Validation questionnaire

    Measured: Baseline

  2. Validation questionnaire

    Measured: month 6

  3. Weekly questionnaire based on PRO CTC-AE

    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…

    Measured: up to 26 weeks

  4. EORTC QLQ-C30

    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).

    Measured: Baseline

  5. EORTC QLQ-C30

    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).

    Measured: week 6

  6. EORTC QLQ-C30

    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).

    Measured: week 12

  7. EORTC QLQ-C30

    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).

    Measured: week 18

  8. EORTC QLQ-C30

    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).

    Measured: week 24

  9. QLQ-LC13

    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).

    Measured: baseline

  10. QLQ-LC13

    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).

    Measured: week 6

  11. QLQ-LC13

    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).

    Measured: week 12

  12. QLQ-LC13

    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).

    Measured: week 18

  13. QLQ-LC13

    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).

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start1 Feb 2019
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712149
Sponsor's protocol ID
FU- Lung cancer - 001
Status last verified
Jan 2021
First submitted
18 Dec 2020
Last updated
15 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Misplon S, Marneffe W, Himpe U, Hellings J, Demedts I. Evaluation of the implementation of Value-Based Healthcare with a weekly digital follow-up of lung cancer patients in clinical practice. Eur J Cancer Care (Engl). 2022 Nov;31(6):e13653. doi: 10.1111/ecc.13653. Epub 2022 Jul 12.

    PubMed 35819130

Questions about this trial

What is this clinical trial studying?

A study testing Weekly digital follow up in people with Lung Cancer, run by Hasselt University at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the response rates on the digital weekly questionnaire (time frame: up to 26 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712149, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.

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