Clinical trial NCT03608410: Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet
Official title: ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Patient reported outcomes
Internet
TelePRO
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Danish Lung Cancer Group
First posted: 2018-08-01
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: This multicenter RCT study enrolls patients diagnosed with stage IV og incurable stage III lung cancer who has non-progressive disease at first evaluation scan. Patients in follow-up or maintenance therapy are eligible.

492 patients will be included in the study with 246 patients in each group.

Intervention In the experimental arm, patients will be asked to fill in a web-based Patient Reported Outcome (PRO) questionnaire every week. If one of the reported symptoms worsens and exceed a predefined threshold of severity, a notification is automatically sent to the hospital. A nurse will review til questionnaire and contact the patient for verification of symptoms. If progression of disease is suspected, a CT scan will be made. Otherwise, the nurse will schedule a visit at the clinic for physical examination and evaluation by a clinician. If progressive disease is not suspected, supportive care will be adjusted and the patient will continue follow up according to the usual schedule.

The interventions ends in case of progressive disease.

Evaluation Baseline CT-scan of thorax and upper abdomen is performed prior to initial treatment and an evaluation CT scan at the time of enrolment. CT scans will be repeated for assessing signs of progression due to standard follow-up procedures in both groups. If progressive disease is suspected based on symptom development, the following scan will be rescheduled to as soon as possible.

Quality of life (QoL) will be measured in both groups using EORTC (European Organisation for Research and Treatment of Cancer) QOL-C30 / LC13 and HADS (Hospital Anxiety And Depression Scale) quality of life questionnaires every 2 month during the study period.

Objectives The primary objective is to test if supplementary weekly PRO monitoring increases overall survival in a Danish Lung Cancer population

Monitoring Clinical decisions taken on the basis of PRO notifications will daily be registered in the software system by the clinicians. Patient responses to questionnaires and PRO-notification handling by the clinical staff will be monitored by Primary Investigator.

End points will be entered by local site investigators.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.
3. Diagnosis proven by cytology or histology
4. Age ≥ 18 years
5. Performance status (PS) ≤ 2 within 15 days before enrolment
6. First evaluation CT scan performed within four weeks from enrolment
7. Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail system)
8. 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
     * Any combination of the above-mentioned treatment modalities Patients are eligible regardless of whether they at the time of inclusion continue maintenance treatment or not

Exclusion Criteria:

1. Progressive disease at first evaluation scan
2. Persons deprived of liberty or under guardianship or curators
3. 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
4. Pregnant or breastfeeding women
5. 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
measure: Type of treatment at time of progression
timeFrame: 2 years
measure: Quality of life (QOL) measured by EuroQol EQ-5D-5L.
timeFrame: 2 years
measure: Quality of life measured by EORTC QLQ C30/LC13.
timeFrame: 2 years
measure: HADS score (Hospital Anxiety And Depression Scale)
timeFrame: 2 years
measure: Qualitative interviews
timeFrame: 2 years
measure: Baseline questionnaires of non-participants
timeFrame: 2 years
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of oncology, Regional Hospital West Jutland
Study officials:
affiliation: Department of Oncology, Regional Hospital West Jutland
name: Rasmus Friis, MD
role: PRINCIPAL_INVESTIGATOR
References: