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Enrolling by Invitation

NCT Number: NCT02312830

Belgian Cross-sectional Allogeneic Transplant Survivor Study

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Hematopoietic Stem Cell Transplantation, Allogeneic

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: BE-C@TS

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2014
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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