Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period.

In case of alarming symptoms reported in the questionnaire, an alert is automatically sent to the hospital. The clinicians will contact the patient, confirm the symptoms and intervene according to standard practice.

Weekly questionnaires

Rasmus Friis, MD

The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.

This pilot study will test if the use of AmbuFlex (a generic on-line system for self-recorded patient reported outcomes) is feasible for a following randomized trial (PRO-WIDE trial - Patient Reported Outcomes used for Weekly Internet-based DEtection of progressive disease in lung cancer; a randomized controlled trial). The RCT (randomized controlled trial) 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 symptoms and the patient will be contacted by the clinicians.

In the pilot study, initial interviews with 7-10 patients will explore possible missing items and conceptual issues in the questionnaire. Based on the results an adjustment of the questionnaire will be considered.

Then the system including the alert trigger mechanism will be tested on 20 patients in medical antineoplastic treatment for three consecutive weeks. Acceptability, usability and relevance will be evaluated by a questionnaire at the end of the study period. Inclusion-rate, number of alerts per completed questionnaire and time usage of alert-management will be registered. For final evaluation, interviews with two nurses and two doctors will be made at the end of the study.

Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients

Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study

Measured by an evaluation questionnaire at the end of the pilot study categorized according to the specified topics with 5 response items for each question. All responses will be presented in a comprehensive chart.

Number of included patients per screened patients Reasons for non-participation

Minutes spent per alert Minutes spent per telephone call

Identified through interviews with 2 nurses and 2 MDs after the study period

Identified through interviews with 7-10 patients prior to the pilot study.

Number of alerts sent to the hospital per questionnaires completed

Danish Cancer Society

Danish Lung Cancer Group

Regional Hospital West Jutland

MD, Principal Investigator

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients will complete weekly symptom monitoring PROMs. If a symptom exceeds the thresholds for clinical importance, a registered nurse will contact the patient, confirm the symptoms and coordinate the further clinical procedure in line with standard practice.

The trial is a feasibility study of a patient-reported outcome (PRO) monitoring for patients with multiple myeloma. Patients will report weekly PROs during treatment at our outpatient unit. The trial will describe the development of treatment-specific item lists to adequately capture relevant symptoms during therapy, evaluate the feasibility of the weekly symptom monitoring, and evaluate the healthcare professional usage of the system in clinical practice.

The trial is a feasibility study of a patient-reported outcome (PRO) monitoring for patients with multiple myeloma. Patients will report weekly PROs during treatment at our outpatient unit. The trial will describe the development of treatment-specific item lists to adequately capture relevant symptoms during therapy, evaluate the feasibility of the weekly symptom monitoring, and evaluate the healthcare professional usage of the system in clinical practice.

The item lists will supplement an already established patient-reported outcome measure (PROM) implementation for the Austrian Myeloma Registry (AMR) at the Department of Hematology in Innsbruck. For the development of the treatment-specific item lists, a review of the literature for symptoms reported in clinical trials of the respective treatment regimens will be conducted. Then, a consensus panel of multiple stakeholders will discuss the symptoms and relevant issues for each treatment group. In an iterative process, the item lists will be developed to capture the most relevant and clinically important symptoms during active therapy to maximize clinical usage.

The observational part of the trial will then test the feasibility of the electronic symptom monitoring and the treatment-specific item lists. Patients will be recruited who are already participating in a routine care patient-reported outcome monitoring. They will be given access to the web-based patient portal and asked to complete weekly assessments using the treatment-specific item lists. In larger intervals (every 6 weeks), they will also be asked to complete a larger questionnaire battery using the EORTC QLQ-C30 and the treatment-specific module (EORTC QLQ-MY20). In the patient portal, patients will also be able to review their own results and receive feedback and self-management advice. Patients will also receive reminders to remind them to use the patient portal.

For healthcare professionals, the system will display the results of the PROMs and trigger alerts if patients reach thresholds for clinical importance. A clinical nurse will monitor the recently completed PROMs and contact patients who exceed the thresholds.

Patients will stay on the symptom monitoring as long as they receive active treatment. They may be excluded if they move to stationary care, depending on their health status or if they want to end the monitoring. The feasibility of the weekly monitoring and items lists will be evaluated and patient feedback to the patient portal and item lists will be recorded and analysed.

Feasibility Study of an ePRO Monitoring for Patients With Multiple Myeloma and Development of Item Lists

Feasibility Study of a Electronic Patient-Reported Outcome (ePRO) Monitoring for Patients With Multiple Myeloma and Development and Evaluation of Treatment-specific Item Lists

assessed via a questionnaire, after six weeks in the program or after using the portal 3 times (whichever occurs first); ratings are provided on a 1 to 4 scale ("not at all" to "very much", higher scores are better); the evaluation questionnaire was created for the study

Calculated as the number of completed assessments divided by the number of expected assessments.

Number of missing items in the symptom item sets

The frequency of clinical alerts in the system (appropriateness of thresholds) and the interventions that were taken in response to the alerts will be investigated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients	NCT03529851	Lung Cancer Sta...	Weekly question...	18 Years -	Regional Hospital West Jutland
Feasibility Study of an ePRO Monitoring for Patients With Multiple Myeloma and Development of Item Lists	NCT05036863	Multiple Myelom...	Weekly question...	18 Years -	Medical University Innsbruck
Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients	NCT03529851	Lung Cancer Sta...	Weekly question...	18 Years -	Regional Hospital West Jutland

Spots Global Cancer Trial Database for weekly questionnaires