Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Weekly symptom monitoring

Web-based weekly symptom monitoring in addition to standard follow-up

Group Type EXPERIMENTAL

Weekly symptom monitoring

Intervention Type OTHER

Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire

Standard care

Standard follow-up according to guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No