Clinical trial NCT03377010: UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors
Official title: UF-BMT-HSCT-001: A Non-Interventional Study Evaluating the Quality of Diet in Allogeneic and Autologous Hematopoietic Stem Cell Transplant Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Neoplasm
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both males and females who have a medical history of allogeneic or autologous hematopoietic stem cell transplant (HSCT), irrespective of the disease. For the purpose of this study, HSCT survivor is defined as subjects one or more years after allogeneic or autologous HSCT without disease relapse, active graft-versus-host disease, or active infection.

Brief summary: This is a single center, cross-sectional, non-interventional study aimed at the nutritional intake of long-term health of allogeneic or autologous hematopoietic stem cell transplant (HSCT) survivors.

Detailed description: Higher rates of comorbidity among hematopoietic stem cell transplant (HSCT) survivors support the need for lifestyle interventions that target this vulnerable population. Comprehensive evaluation of the nutrient intake will provide adequate information necessary for develop of a targeted nutritional intervention in order to achieve specific nutritional need and improve long-term health of HSCT survivors. The cross-sectional design of this study has been selected for the timely collection of subject reported nutrient intake data. The intended study is strictly observational.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures for subjects enrolled from the cancer registry.
* Both males and females ≥ 18 years of age.
* A medical history of allogeneic or autologous hematopoietic stem cell transplant (HSCT), irrespective of the disease. For the purpose of this study, HSCT survivor is defined as subjects one or more years after allogeneic or autologous HSCT without disease relapse, active graft-versus-host disease, or active infection. Subjects with chronic graft versus host disease who are on stable dose of immunosuppressant (or being tapered off of immunosuppressant) over the past 3 months will be eligible.
* Study participants must have the ability to complete the questionnaires through one of the previously stated mechanisms.
* English speaking due to the logistics of the questionnaires and phone contact included in this study.

Exclusion Criteria:

* Subjects demonstrating an inability to comply with the study procedures.

Primary outcomes:
measure: Diet intake
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Nosha Farhadfar, MD
role: PRINCIPAL_INVESTIGATOR
References: