Pilot Digital Follow-up of Lung Cancer

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: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Weekly digital follow up

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Roeselare, Belgium, 8800
    • AZ Delta

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	up to 26 weeks
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	up to 26 weeks
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	up to 26 weeks
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	month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation questionnaire		Baseline
Validation questionnaire		month 6
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…	up to 26 weeks
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).	Baseline
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).	week 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).	week 12
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).	week 18
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).	week 24
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).	baseline
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).	week 6
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).	week 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).	week 18
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).	week 24

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: AZ Delta
• Investigators: Principal Investigator: Wim Marneffe, prof. dr., Hasselt University; Study Chair: Veerle Ross, dr., Hasselt University

Publications and helpful links

General 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 Jul 12:e13653. doi: 10.1111/ecc.13653. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID 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