Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer (LUCA-S)

November 11, 2022 updated by: Mats Lambe

The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up.

Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption.

All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years.

By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mats P Lambe, MD, PhD
  • Phone Number: +46707715655
  • Email: mats.lambe@ki.se

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytology proven non-small cell lung cancer (NSCLC)
  • NSCLC stage III or IV
  • ≥ 18 years
  • ECOG performance status 0- 2
  • Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment
  • Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment
  • Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis)
  • Initial web-based application score of ≤ 6
  • Basic computer literacy
  • Bank-ID (electronic identification system) and access to "1177 Vårdguiden"
  • The subject has given written consent to participate in the study

Exclusion Criteria:

  • Symptomatic brain metastases
  • Pregnancy, breastfeeding, or planned pregnancy
  • Persons under guardianship or deprived of liberty
  • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
  • Treatment or disease which, according to the investigator, can affect treatment or study results
  • Ongoing participation in another interventional clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weekly symptom monitoring
Web-based weekly symptom monitoring in addition to standard follow-up
Other: Weekly symptom monitoring
Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire
No Intervention: Standard care
Standard follow-up according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months.
Overall survival
From date of randomization until the date of death from any cause, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.
First confirmed disease progression
From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.
Performance status
Time Frame: At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.
Performance status will be evaluated according to the ECOG Perfomance Status Scale (Scale 0-5: 0 = fully active, able to carry on all pre-disease performance without restriction, 5=dead).
At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.
Proportion of patients starting second-line anti-neoplastic treatment
Time Frame: Assessed up to 24 months.
Proportion of patients starting second-line anti-neoplastic treatment within 12 weeks from date of confirmed disease progression after randomization.
Assessed up to 24 months.
Quality of life
Time Frame: At baseline and every three months, assessed up to 24 months.
Assessed by EORTC QLQ-C30-LC13 questionnaire. The QLQ-C30 is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
At baseline and every three months, assessed up to 24 months.
Symptoms of depression
Time Frame: At baseline and every three months, assessed up to 24 months.
Assessed by the Patient Health Questionnaire (PHQ9). Score 0 (no symptoms) to 27 (severe symptoms).
At baseline and every three months, assessed up to 24 months.
Number of days of in-hospital care
Time Frame: Assessed up to 24 months.
Health care consumption will be assessed as number of days of in-hospital care during study participation.
Assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mats Lambe

Collaborators

Uppsala University Hospital
Gävle Hospital

Investigators

  • Principal Investigator: Gunnar L Wagenius, MD,PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 18, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2027

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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