Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet

NCT03608410 | Completed

• 3 other identifiers: ProWideR184-A11805-17-S572017-41-5251
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial (RCT) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming or worsening symptoms and the patient will be contacted by the treating clinicians.

Conditions

Lung Cancer

Keywords

Patient reported outcomes; Internet; TelePRO

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (8)

• ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression

  2 years

• Progression free survival

  2 years

• Type of treatment at time of progression

  2 years

• Quality of life (QOL) measured by EuroQol EQ-5D-5L.

  2 years

• Quality of life measured by EORTC QLQ C30/LC13.

  2 years

Study Arms (2)

PRO intervention

EXPERIMENTAL

Weekly PRO questionnaires Quality of life every 2 months

Other: Weekly Internet based PRO questionnaires

Standard of care

NO INTERVENTION

Quality of life every 2 months

Interventions

Weekly Internet based PRO questionnaires OTHER

If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital.

PRO intervention

Eligibility Criteria

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

You may qualify if:

• Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction treatment\* for lung cancer and have no sign of progressive disease at first evaluation CT scan.
• Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.
• Diagnosis proven by cytology or histology
• Age ≥ 18 years
• Performance status (PS) ≤ 2 within 15 days before enrolment
• First evaluation CT scan performed within four weeks from enrolment
• Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail system)
• Patient has given his/her written informed consent before any specific procedure from protocol
• Induction treatment includes:
• Standard doublet chemotherapy
• Immunotherapy
• Targeted therapy
• Palliative radiotherapy
• Local treatment of oligometastatic disease, including surgery and stereotactic radiotherapy

You may not qualify if:

• Progressive disease at first evaluation scan
• Persons deprived of liberty or under guardianship or curators
• Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
• Pregnant or breastfeeding women
• Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol committee.

Sponsors & Collaborators

• Regional Hospital West Jutland: lead
• Danish Cancer Society: collaborator
• Danish Lung Cancer Group: collaborator

Study Sites (1)

Department of oncology, Regional Hospital West Jutland

Herning, 7400, Denmark

Location

Related Publications (1)

• Friis RB, Pappot H, Hjollund NH, McCulloch T, Holt MI, Persson GF, Wedervang K, Clausen MM, Wahlstrom S, Hansen KH, Rasmussen TR, Dalton SO, Jakobsen E, Linnet H, Skuladottir H; Danish Lung Cancer Group. Remote Symptom Monitoring of Patients With Advanced Lung Cancer (The ProWide Study): A Randomized Controlled Trial. JCO Oncol Pract. 2025 Jun;21(6):813-823. doi: 10.1200/OP-24-00562. Epub 2024 Dec 10.

  PMID: 39657078 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

• Rasmus Friis, MD

  Department of Oncology, Regional Hospital West Jutland

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process. A text message reminder is sent weekly for patients in the intervention group by the system. Quality of Life questionnaires will automatically be sent via a safe internet connection to participants in both groups every 2 months.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 1, 2018
• Study Start: September 18, 2018
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

DK (1)