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

Mats Lambe

Status

Not yet enrolling

Conditions

Lung Cancer

Treatments

Other: Weekly symptom monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05621902

102877

Details and patient eligibility

About

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.

Full 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.

Enrollment

398 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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