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NCT ID: NCT05947903 Not yet recruiting - Cancer Clinical Trials

Validation of the European Oncology Quality of Life Toolkit

Start date: June 15, 2024
Phase:
Study type: Observational

The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries. The EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity. - Live-CAT version, to validate the static and dynamic versions against each other. - EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.

NCT ID: NCT05937659 Not yet recruiting - Cancer Clinical Trials

Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

Start date: November 15, 2024
Phase:
Study type: Observational

This study will assess the feasibility of incorporating biometric data via wearable health technology (WHT) into the radiation oncology (RO) clinic workflow for patients receiving concurrent radiation therapy and systemic therapy (CRT) for cancer. The investigators hypothesize that a practical workflow could be created within a busy community RO practice that will allow providers and patients to readily appreciate physiologic declines during concurrent CRT. Subjects will be asked to wear a device as part of this study that will collect their biometric data (heart rate, number of steps taken per day, etc) called a WHT device throughout their treatment and for 4 weeks afterward. Subjects will be asked to upload the data from their devices onto the computers in the clinic for the assessment.

NCT ID: NCT05911672 Not yet recruiting - Cancer Clinical Trials

Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer Care Using Innovative Approaches

PRICE
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Patient Reported Outcome Measures (PROMs) are patients' reports of their symptom experience, quality of life and functionality. These measures are used as an endpoint to clinical trials but rarely integrated into routine cancer care. Moreover, they are resource intensive and prone to retrospective biases. PRICE project aims to develop and evaluate a digital health tool (ePROM), collecting PROMs at the clinic and additional Ecological Momentary Assessment (EMA) of PROMs using a mobile application. In addition it tests whether patients who are identified to have elevated pain, fatigue, and stress will benefit from an Ecological Momentary Intervention (EMI) based on Virtual Reality environments. EMA can overcome biases and barriers in PROM assessment whilst EMI can offer an easy and possibly cost-effective intervention until patients re-visit the clinic. The project can contribute to monitoring patient data and achieve viable health systems. It is also timely since digital health tools are considered the future of oncology care but often lack robustness in development and evaluation. Patients treated for cancer at the German Oncology Centre in Cyprus will be randomized into three conditions: (a) Full Intervention (patients who are prompted to use the EMI based on their EMA data; (b) Partial Intervention (patients who are prompted to use the EMI irrespective of their EMA data); (c) Control (patients who only provide their EMA without an EMI). A dissemination strategy will ensure findings and innovation are available to the public, clinicians, students and policy-makers.

NCT ID: NCT05904782 Not yet recruiting - Cancer Clinical Trials

Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer

Start date: November 1, 2024
Phase:
Study type: Observational

To learn more about the experience and wellbeing of people who provide care for cancer patients.

NCT ID: NCT05896371 Not yet recruiting - Prostate Cancer Clinical Trials

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

PRODIGY-1
Start date: January 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins. The main questions it aims to answer are: - To establish a dosimetry-based, personalized regime of 177Lu-PSMA - To report on the efficacy of personalized 177Lu-PSMA Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.

NCT ID: NCT05889312 Not yet recruiting - Cancer Clinical Trials

Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET

Start date: September 2023
Phase:
Study type: Observational

Prospective single centre non-randomised exploratory observational study to measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.

NCT ID: NCT05881070 Not yet recruiting - Cancer Clinical Trials

Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy

MANNER
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

NCT ID: NCT05878782 Not yet recruiting - Cancer Clinical Trials

the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

OCEAN-OT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled superiority trial is to evaluate the impact of occupational therapy assessment and intervention on the quality of life of elderly cancer patients. Patients will be randomized into 3 parallel, multicenter arms with patient-reported outcome and blinded evaluator. - Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention. - Experimental group B will have only the MCRO assessment because the occupational problems assessment alone (without intervention) could improve quality of life and occupational performance outcomes, according to the Nielsen, 2019 study - Group C will have the usual cancer management care combining specific treatments and supportive care.

NCT ID: NCT05876676 Not yet recruiting - Cancer Clinical Trials

RDC Biomarker Study

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

Rapid Diagnostic Centres Rapid Diagnostic Centres (RDC) were built to diagnose patients who have common symptoms that occur in cancer, but it is unclear if they have cancer or not. These symptoms include: - Weight loss - Fatigue - Cough - GP suspicion Only 1 in every 10 patients (10%) referred to an RDC will have cancer. Some of the patients with cancer may have been more likely to develop cancer due to inherited or environmental factors. Some of the patients who don't have cancer may also be at higher risk of developing cancer at another time due to inherited or environmental factors. Aims The goal of this observational study is to develop a new blood or non-blood test that could help doctors at RDC: - detect which patients have cancer through a simple and quick blood or non-blood test - detect patients who are at higher risk of having cancer. This is so they can be monitored or guided towards cancer-screening programmes Main End Points - The study will be considered a success if a test or mixture of tests is developed that can correctly sort patients into cancer or non-cancer groups. - Also, the study will be considered a success if a test or mixture of tests can show what type of cancer a patient has if they have cancer. Tests To create this new blood or non-blood test the study will take the following samples from 1000 patients in the RDC Biomarker Study: - Breath samples (around 300 patients) - People with cancer have different levels of chemicals in their breath than people without cancer. The study hopes to develop a breath test which could show if a patient has cancer or not. - Blood samples ( around 1000 patients) - The study hopes to develop a blood test that could show if a patient has cancer or not - Saliva samples (around 1000 patients) - For many cancers, while there is a genetic component there is no one single gene that causes cancer. Instead, it can be a combination of hundreds of genes that causes the risk of cancer in a person to go up. The study hopes to develop a test which could provide a risk score. This risk score is called a 'polygenic risk score' which would tell doctors how likely a patient is to get cancer. Method Patients who meet the criteria to be able to join the study will be asked either via telephone before their appointment, or face-to-face at an appointment at the RDC if they would like to join the study. If they agree to join the study they will read a patient information sheet and sign a consent form to say they understand what the study requires. The patient will then provide blood and saliva samples and in some cases breath samples at their first appointment. They will be then asked to provide further samples (up to three) at their follow-up appointments. Please see below for samples that will be asked for at each appointment: First appointment: Breath (not all sites), Blood, Saliva (not all sites), Survey Follow-up 1: Any samples that could not be taken at the first appointment Follow-up 2: Any samples that could not be taken at the first appointment The patient will be provided with a Study ID to identify their samples. This is a unique code to identify each person on the study. Only the site that recruited the participant will have access to the personal information that matches which patients is known by which Study ID. All organisations external to the site will only know the patient as the Study ID. An example of the study ID could be RDCRMH001. A trained clinical member of the research team at the RDC will take the sample and ship it to the relevant laboratory for testing. As well as blood and non-blood tests, information about the patients will be collected This includes routinely collected clinical data alongside investigation results. No patient identifiable information such as: - Name - Address - Date of birth - Contact details will be collected, and a Study ID will be used to identify the data. A patient questionnaire will be sent out to patients to complete for each appointment asking questions about the patient's health. The RDC doctors treating the patient will see survey answers before the appointment to allow them to act about anything worrying. For a small group of patients anonymised copies of thier scans from their medical records will also be taken. Study Duration Once the study has recruited 1000 patients, it will close. These patients will then be followed up for 12 months following the date they joined the study.

NCT ID: NCT05874648 Not yet recruiting - Cancer Clinical Trials

PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection

PROFUTURE
Start date: July 7, 2023
Phase:
Study type: Observational

Liquid biopsy technology based on cell-free nucleic acids and protein characteristics has unique advantages and significant application prospects in cancer early detection. The purpose of this study is to collect peripheral blood samples from participants with new diagnosis of cancer and from participants who do not have a diagnosis of cancer in order to develop machine learning models for discovering cancer from non-cancer.