Belgian Cross-sectional Allogeneic Transplant Survivor Study

NCT ID: NCT02312830

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2025-11-30

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.

Conditions

Hematopoietic Stem Cell Transplantation; Hematopoietic Stem Cell Transplantation, Allogeneic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

S57284

Identifier Type: -

Identifier Source: org_study_id