Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy (QOL-ONE PRO-CT)

Associazione Qol-one

Status: Begins enrollment this month

Conditions: Allogeneic Blood and Marrow Transplantation (BMT); Patient Reported Outcome (PRO); Quality of Life; CAR T Cell Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07289087

QOL-ONE PRO-CT

Details and patient eligibility

About

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).

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

162 participants in 2 patient groups

CAR-T

ALLO-SCT