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AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation — AlloCare  

Hematological Diseases Clinical Trial

Official title:
AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Summary

A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.

Clinical Trial Description

The study aims to investigate the effect of a multidisciplinary multimodal intervention in allo-HSCT survivors on survivorship-specific health-related quality of life and late effects. Method: This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase. Population/recruitment: Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group. Intervention: The intervention is multi-modal and multidisciplinary and consists of two main components including individual consultations based on Patient Reported Outcome Data (HM PRO) and web-based digital health support and education. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians. Data Collection: Patient reported Outcome data will be distributed electronically to patients via Redcap and collected at baseline T1, 6 months from allo-HSCT. Post-intervention data collection T2, 12 months from allo-HSCT, and follow-up assessment T3 at 18 months from allo-HSCT. Primary outcome; Changes in Self-reported HRQoL and burden of late effects measured by EORTC-QOL-SURV100. Secondary outcome: Degree of health literacy measured by the Health Literacy Questionnaire (HLQ). Occurrence of Chronic Graft Versus Host Disease measured by Lee Chronic Graft Versus Host Disease Symptom scale ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06281496
Study type Interventional
Source Rigshospitalet, Denmark
Contact Mette Schaufuss Engedal, MSc
Phone +45 51896699
Email mette.schaufuss.engedal@regionh.dk
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date December 1, 2026
View Details
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