Overview
Tab Title Description
Tipo de estudio
ObservationalDescribe la naturaleza de un estudio clínico. Los tipos incluyen los siguientes:
- Estudio observacional, en el que se observan personas y se miden los resultados sin afectarlos.
- Estudio intervencionista (ensayo clínico), en el que se estudian nuevos exámenes, tratamientos, medicamentos, procedimientos quirúrgicos o dispositivos.
- Las investigaciones basadas en expedientes médicos utilizan la información histórica recopilada a partir de los registros médicos de grandes grupos de personas para estudiar cómo evolucionan las enfermedades y qué tratamientos y cirugías son más eficaces.
Identificaciones del estudio
Comité de revisión institucional de la sede
- Scottsdale/Phoenix, Arizona: 19-012702
- Jacksonville, Florida: 19-012702
- Rochester, Minnesota: 19-012702
Información sobre este estudio
Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.
Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.
We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following: age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.