Pilot Digital Follow-up of Lung Cancer

NCT04712149 | Completed

• 1 other identifier: FU- Lung cancer - 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Validation questionnaire

  Baseline

• Validation questionnaire

  month 6

• Weekly questionnaire based on PRO CTC-AE

  up to 26 weeks

• EORTC QLQ-C30

  Baseline

• EORTC QLQ-C30

  week 6

Study Arms (2)

intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Interventions

Weekly digital follow up DEVICE

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

intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• AZ Delta: collaborator

Study Sites (1)

AZ Delta

Roeselare, 8800, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35819130 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wim Marneffe, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Veerle Ross, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 15, 2021
• Study Start: February 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

BE (1)