ISRCTN11232653进行中（未招募）Unknown
Development and feasibility testing of a digital platform to capture patient-reported outcomes (PROs) for CAR-T precision cellular therapies: A multiphase, mixed-methods study (The PRO-CAR-T™ Study)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •WP1: Intervention development
- •Individuals able to provide informed consent who have an interest in patient-reported, digital symptom monitoring for CAR-T cell therapies, including:
- •1. CAR-T patients (aged 18 years or older)
- •2. Their family members/carers
- •3. Healthcare professionals
- •4. Academic researchers
- •5. Policymakers/commissioners
- •6. Industry representatives
- •7. Regulators
- •WP2: Usability testing
- •1. CAR-T patients aged 18 years or older, able to provide informed consent, and willing to use the PRO-CAR-T™ digital system to report their symptoms.
- •2. Healthcare professionals who are members of a CAR-T clinical team in the NHS.
- •WP3: Feasibility study
- •1. CAR-T patients who are aged 18 years or older with a diagnosis of large B-cell lymphoma or acute lymphoblastic leukaemia (adults aged 18-25 years), are eligible for CAR-T cell therapy, and able to provide informed consent.
- •2. Healthcare professionals who are members of the patient’s clinical team with a delegated duty to monitor patients' symptom and side effects reports submitted via the PRO-CAR-T™ digital system.
- •NB.: Participants who do not have a good understanding of English will not be excluded from the study and the use of translators/interpreters will be encouraged.
排除标准
- •WP1: Intervention development
- •1. Individuals unable/unwilling to provide informed consent.
- •2. Individuals < 18 years of age.
- •3. Patients who are not candidates for/recipients of CAR-T cellular therapies.
- •4. Individuals without relevant expertise of CAR-T cellular therapies.
- •5. Individuals unwilling/unable to undertake the protocol activities.
- •6. Individuals deemed appropriate for exclusion by their CAR-T clinical team (i.e., on a palliative care pathway)
- •WP2: Usability testing
- •1. Individuals unable/unwilling to provide informed consent.
- •2. Individuals < 18 years of age.
- •3. Patients who are not candidates for/recipients of CAR-T cellular therapies.
- •4. Patients deemed appropriate for exclusion by their CAR-T clinical team (i.e., on a palliative care pathway).
- •5. Healthcare professionals without relevant expertise in CAR-T cellular therapies.
- •6. Individuals unwilling/unable to undertake the protocol activities.
- •WP3: Feasibility study
- •1. Individuals unable/unwilling to provide informed consent.
- •2. Individuals < 18 years of age.
- •3. Individuals without relevant expertise of CAR-T cellular therapies.
- •4. Individuals unwilling/unable to undertake the protocol activities.
研究者
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