To hear about similar clinical trials, please enter your email below
Trial Title:
Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer
NCT ID:
NCT05621902
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Sweden
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Weekly symptom monitoring
Description:
Patients randomized to the intervention arm will be invited to respond to a web-based
weekly 11-item signs- and symptoms questionnaire
Arm group label:
Weekly symptom monitoring
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 18, 2022
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Mats Lambe
Agency class:
Other
Collaborator:
Agency:
Uppsala University Hospital
Agency class:
Other
Collaborator:
Agency:
Gävle Hospital
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05621902
