Large B-cell lymphoma or acute lymphoblastic leukaemia Cancer
Conditions
Interventions
This study is comprised of three phases or work packages (WP). In WP1 we will design the PRO-CAR-T™ digital system. In WP2 we will work with Aparito Limited, a medical technology company, to build the
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment: Number and proportion (%) of eligible patients who consent to take part. 2. Retention: Number and proportion of patients who complete the 12-month PRO assessment. 3. Adherence: Number of proportion of patients completing the PRO assessment. 4. Number of clinical alerts and number and proportion of patients reporting clinical alerts. 5. Number and proportion of patients who withdraw formally from the study and their reasons for withdrawal. 6. Actions arising from alerts including number and proportion of patients attending clinic, hospitalisation following clinical alert reporting, estimated time between alert and response by clinical team. 7. Number of ad hoc PRO assessments completed and the number and proportion of patients submitting ad hoc PRO assessments. 8. Acceptability of the digital tool will be measured using the Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) at 3-month, 6-months, and 12-months post-infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed