Belgian Cross-sectional Allogeneic Transplant Survivor Study

• Conditions: Hematopoietic Stem Cell Transplantation; Hematopoietic Stem Cell Transplantation, Allogeneic

• Registration Number: NCT02312830
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment.

This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.

Detailed Description

This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.

Study Timeline

• Study First Submitted: 2014-10-15
• Study Start: 2014-11
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Ability to read and write in Dutch
• Age above 18 years at time of transplant
• Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx)
• Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016
• Willing to provide oral and written consent

Exclusion Criteria

• Unable to communicate fluently in Dutch
• Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation
• Presenting with relapse or other major illness, with less than 6 months expected survival
• Hospitalized for a life-threatening condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation	The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included.	This is a cross sectional study, assessing several aspects of survivorship with multiple validated questionnaires (EQ5D, PHQ9, GAD, SFQ, etc). These questionnaires are only taken once in all survivors approached for the study.