Pilot Digital Follow-up of Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712149
• Other study ID #: FU- Lung cancer - 001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stage IV lung cancer,

• speak sufficient Dutch

• willing to participate

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Delta	Roeselare

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	AZ Delta

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Validation questionnaire		Baseline
Secondary	Validation questionnaire		month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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