Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

Chemotherapy Chemoradiotherapy Radiotherapy Immunotherapy Or a combination of above

SABR combined immunotherapy

Radiotherapy combined immunotherapy

Decision tool

Iva Halilaj, Msc

Relinde Lieverse, MD

Philippe Lambin, Prof. MD

This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate.

We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision.

ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)

A lung cancer patient might want to take part in the ImmunoSABR phase 2 trial (NCT03705403). Before they can decide, it is important that the patients understand why the research is being done and what it would involve for them.

This tPDA will give information about this trial via text, small movies, quiz and preferences. In the end, the patient will receive an overview of their choices.

Detailed Description ImmunoSABR:

IMMUNOSABR will include 126 patients. In this single-stage controlled randomised open-label phase II trial, we aim to demonstrate an absolute increase in progression-free survival (primary endpoint). PFS will be determined as the time between randomisation and disease progression, according to RECIST 1.1, death due to any cause or last patient contact alive and progression-free. Patients will be randomized between control (no immunocytokine) and experimental arms (with immunocytokine L19-IL2) in a 1:1 ratio. The accrual period will be 29 months (or 2.41 years), and the minimum follow-up will be 18 months (or 1.5 years), making the total study duration 47 months. Comparison between control and experimental arms will be made using the Log-Rank statistic. This test for superiority will be one-sided with the desired type I error of 0.10 and power of 0.90.

Patients enrolled in the trial will be randomised into the control arm (C-arm) or experimental arm (E-arm).

C-arm: Standard of Care (SOC) according to the local and national guidelines: (wait and see or surgery and/or chemotherapy and/or standard (symptomatic) radiotherapy and/or SABR, oligometastatic disease.

E-arm: SABR (oligometastatic disease) or radiotherapy (diffuse disease) + L19-IL2 up to 6 cycles (+ aPD(L)1 if SOC) The expected 1.5-year PFS is 15% in the C-arm and 35% in the E-arm. A sample size of 116 patients (58 patients per treatment arm) is needed to show this difference of 20% in PFS, using a logrank test with a two-sided alpha of 0.05 and power of 85%. Patients will be evenly divided over the two arms. Assuming a drop-out rate of 10%, a total of 126 patients (63 per arm) need to be included.

Primary objective The main objective of the trial is to test if the activity of the combination of (SAB)R and L19-IL2 in patients with metastatic NSCLC will result in improved progression-free survival (PFS) compared to the SOC.

Secondary Objectives

Assessment of the PFS of the patient cohort, at 5 years after randomisation. Assessment of the overall survival of the patient cohort, at 5 years after randomisation.

To assess the toxicity of this treatment schedule; To assess Quality of Life (QoL); To assess the occurrence of an Out of Field Radio-Immune (OFRI) response / abscopal effect using imaging; To assess the occurrence of an In Field Radio-Immune (IFRI) response using imaging; To perform correlative biomarker studies related to treatment response.

Exploratory endpoints:

Correlative biomarker studies:

Tumour tissue: e.g EDB expression, non-synonymous mutations, immune monitoring; Blood: e.g. EDB expression, cfDNA, and immune monitoring; Radiomics on CT and if available MRI; Faeces: diversity in microbiota. iRECIST Tumour grow kinetics

Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2

Patients' decisional needs (development phase):semi-structured interviews with patients about the decision about their treatment, and what information the patients need to make.

Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire measure to what extent the decision aid is easy to use. Answers will be clear for the patient; agree, neutral, disagree.

Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and ImmunoSABR clinical trial. Answers will be clear for the patient; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patient's preference to participate in medical decisions will be assessed using the 3-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and ImmunoSABR clinical trial . Questions and answers will be clear for the patient; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

Patients satisfaction with the tPDA will be tested via questions with predefined answers; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patients recommendation regarding the tPDA will be tested via questions with predefined answers; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Maastricht University

Immune System Diseases

Hypersensitivity

Robert Friedman, MD

The purpose of this study is to develop a tool that can more accurately assess the intensity and kind of physical activity that a person performs. The experimental tool, which will use a mobile computing device as a way of automatically identifying when a certain activity is being performed and at what intensity, will be tested against a self reported paper diary of activities performed on a day to day basis. It is hoped that this study will increase understanding of the health benefits of certain types of physical activity performed in the home.

Engaging in regular physical activity that requires a moderate to vigorous effort is related to good health and a reduced risk of a multitude of diseases. Currently physical activity and health promotion research is limited by self- report data that is confounded by participants' ability to accurately remember and record their physical activity. A potentially new method of accurately assessing moderate-intensity physical activity is called context sensitive- ecological momentary assessment (CS-EMA). Mobile computing devices (personal computing devices, PDAs) that automatically identify when a specific type of physical activity (e.g., moderate-intensity physical activity) is being performed has the potential to provide valuable objective data for naturalistic, experimental, and clinical intervention research purposes, and has the potential for educational, recreational, and clinical applications. The goal of this exploratory study is to assess the accuracy of two methods of collecting data on moderate-intensity physical activity. The study will compare the use of a paper diary to collect self-reported data on moderate-intensity physical activities performed throughout the day to self-reported data collected using ecological momentary assessment methods which are facilitated by a PDA that cues the participant to record when specific intensity levels of physical activity are achieved. This study will also develop algorithms that will automatically identify specific types of physical activities being performed. The data collected from the heart rate monitor, motion sensor, and information requested directly from the participant via the PDA interface will be used to train pattern recognition systems to classify the intensity and type of physical activity being performed by the participant. This study will contribute to research on context- awareness and human activity recognition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2	NCT04604470	NSCLC Stage IV Lung Cancer Non Small Cell ... Metastatic Canc...	Decision tool	18 Years -	Maastricht University
Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2	NCT04604470	NSCLC Stage IV Lung Cancer Non Small Cell ... Metastatic Canc...	Decision tool	18 Years -	Maastricht University
The Development and Testing of an Electronic Tool to Measure Physical Activity in Domestic Settings	NCT00207181	Cancer		18 Years -	Boston Medical Center

Spots Global Cancer Trial Database for pda

Every month we try and update this database with for pda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pda

Every month we try and update this database with for pda cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.