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Enrolling by invitation Observational

Quality of Life in Young Patients Undergoing Bone Marrow Transplant

NCT06476691 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2025-05-01
Last updated
2025-07-08

Condition(s) studied

Quality of Life After Stem Cell Transplantation

Study summary

Young patients at the age of 18-29 years undergoing allo-HCT lack studies which specifically describe their unique problems. Validated EORTC QLQ-C30 questionnaires aimed at either children or adults have been used in international studies. But there has been a lack of a questionnaire design that can capture health-related quality of life after cancer treatment with greater relevance for the young patient. Together with young patients and hospital professionals quality of life-related health concerns and unique social and emotional problems were found that were more relevant to the young than to children and adults and validation of a new youth-relevant EORTC QLQ-AYA (AYA: adolescent and young adult) scheme that includes an extra focus on the youths problems has been carried out among young cancer patients. This questionnaire will be made available for testing in our patient population of allo-HCT patients and can for the first time map the quality of life of younger alloHCT patients.

This study includes two cohorts of patients. One is a retrospective/cross sectional study cohort of patients previously undergoing transplantant between 2010 and 2022, the other is a smaller prospective study examining the QoL before and after transplant.

The knowledge from the surveys will be important for health professionals understanding of the young peoples specific problems. Mapping and paying attention to the problems and possible solutions will be an essential component in helping the young allo-HCT patient.

The results will be correlated with clinical data: age, diagnosis, pretreatment with or without high-dose whole-body irradiation, and the nature and degree of late sequelae (survivor toxicity and rehabilitation)

Eligibility

Sex
ALL
Min age
18 Years
Max age
29 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged between 18-29 years who are scheduled for or have already undergone alloHCT at Rigshospitalet in the period 2000-2022 * Patients who have consented to the study Exclusion Criteria: * Patients who do not meet the inclusion criteria or who are not able to consent or participate in a clinical study

Primary outcome measure(s)

  • To investigate the quality of life in 18-29-year-old young people during and after alloHCT — In the prospective study each young person will be followed up with questionnaires before (approx. 3 weeks before alloHCT vs. the preliminary examination) and after alloHCT (+3 months, +½ year, +1 year, +2 years after alloHCT
    Using validated questionaires, including a newly developed and validated specifically youth-oriented EORTC QLQ-AYA

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet, Denmark Copenhagen Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06476691 on ClinicalTrials.gov ↗ ← All trials in Denmark