UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors

Completed

• Conditions: Hematopoietic Neoplasm
• Interventions: Other: Dietary intake -Food Frequency Questionnaire; Other: Receptivity to Participating in Diet Interventions

• Registration Number: NCT03377010
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Study Start: 2017-12-14
• Study First Posted: 2017-12-19
• Status Verified: 2019-09
• Primary Completion: 2019-09-13
• Study Completion: 2019-09-13
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematopoietic Stem Cell Transplant (HSCT) Survivor	Receptivity to Participating in Diet Interventions	Study participants will be administered a Dietary Intake - Food Frequency Questionnaire and a Receptivity to Participating in Diet Interventions Questionnaire.
Hematopoietic Stem Cell Transplant (HSCT) Survivor	Dietary intake -Food Frequency Questionnaire	Study participants will be administered a Dietary Intake - Food Frequency Questionnaire and a Receptivity to Participating in Diet Interventions Questionnaire.

Primary Outcome Measures

Name	Time	Method
Diet intake	1 month	To evaluate the diet intake of long-term survivors of HSCT

Trial Locations

Locations (1)

UF Health Cancer Center; 🇺🇸 Gainesville, Florida, United States