Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Quality of Life, Patient Reported Outcome (PRO), Allogeneic Blood and Marrow Transplantation (BMT), CAR T Cell Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Real-World Observational Study on Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation (Allo-SCT) and CAR-T Therapy
Overview
3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Patients will be enrolled at hospital admission for the index inpatient procedure and followed through the inpatient stay (admission → discharge). The study is non-randomized and designed to describe trajectories of symptoms and HRQoL and to estimate the between-group difference in deterioration of HM-PRO scores (primary estimand: mean difference in change score, CAR-T vs allo-SCT).
Primary outcome measures
- To assess and compare short-term patient-reported outcomes [PROs (symptom burden and QoL impact)] between patients receiving allo-SCT and CAR-T therapy using the HM-PRO questionnaire (Impact Scale, Symptoms Scale) from admission to hospital discharge [Time frame: 3 MONTHS]
Secondary outcome measures (5)
- To describe PRO trajectories during hospitalization [Time frame: 3 MONTHS]
- To assess differences in PROs based on disease type (e.g., Leukemia, lymphoma, myeloma) [Time frame: 3 MONTHS]
- To assess differences in PROs based on disease status (remission vs progression) [Time frame: 3 MONTHS]
- To assess differences in PROs based on treatment line (first-line vs multiple lines) [Time frame: 3 MONTHS]
- To validate the use of the HM-PRO in the context of inpatient care for advanced therapies. [Time frame: 3 MONTHS]
Eligibility criteria
Inclusion criteria
- Diagnosed with a hematologic malignancy (e.g., leukemia, lymphoma, multiple myeloma)
- Undergoing either allogeneic SCT or CAR-T therapy
- Able and willing to provide written informed consent
- Sufficient Italian proficiency to complete the HM-PRO
- Signed informed consent
Exclusion criteria
- Cognitive or physical impairments that preclude the ability to complete questionnaires
- Estimated life expectancy < 7 days at the time of admission
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07289087 · QOL-ONE PRO-CT