Clinical trial NCT04712149: Pilot Digital Follow-up of Lung Cancer
Official title: Pilot Study - Measurement of Cost, Outcome and Patient Experience of a Digital Weekly Follow up of Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: AZ Delta
First posted: 2021-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Assess the response rates on the digital weekly questionnaire
timeFrame: up to 26 weeks
measure: Assess the Response on the validation questionnaire at Baseline and at Week 26
timeFrame: up to 26 weeks
measure: Assess the workload of responding to the alerts on the weekly questionnaire for the care team
timeFrame: up to 26 weeks
measure: Assess the clinical utility of the alerts for the care team
timeFrame: month 6
Secondary outcomes:
measure: Validation questionnaire
timeFrame: Baseline
measure: Validation questionnaire
timeFrame: month 6
measure: Weekly questionnaire based on PRO CTC-AE
timeFrame: up to 26 weeks
measure: EORTC QLQ-C30
timeFrame: Baseline
measure: EORTC QLQ-C30
timeFrame: week 6
measure: EORTC QLQ-C30
timeFrame: week 12
measure: EORTC QLQ-C30
timeFrame: week 18
measure: EORTC QLQ-C30
timeFrame: week 24
measure: QLQ-LC13
timeFrame: baseline
measure: QLQ-LC13
timeFrame: week 6
measure: QLQ-LC13
timeFrame: week 12
measure: QLQ-LC13
timeFrame: week 18
measure: QLQ-LC13
timeFrame: week 24
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
affiliation: Hasselt University
name: Wim Marneffe, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Veerle Ross, dr.
role: STUDY_CHAIR
References:
citation: 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.