Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet (ProWide)

Regional Hospital West Jutland

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Weekly Internet based PRO questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT03608410

ProWide

R184-A11805-17-S57 (Other Grant/Funding Number)

2017-41-5251 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

PRO intervention

Experimental group

Description:

Weekly PRO questionnaires Quality of life every 2 months

Treatment:

Other: Weekly Internet based PRO questionnaires

Standard of care

No Intervention group

Description:

Quality of life every 2 months