Belgian Cross-sectional Allogeneic Transplant Survivor Study

Hematopoietic Stem Cell Transplantation Clinical Trial

— BE-C@TS  

Official title:

Belgian Cross-sectional Allogeneic Transplant Survivor Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02312830
• Other study ID #: S57284
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 15, 2014
• Last updated: June 29, 2016
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: June 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Hematopoietic Stem Cell Transplantation, Allogeneic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation	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.	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.	No