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

Hematopoietic Neoplasm Clinical Trial

Official title:

UF-BMT-HSCT-001: A Non-Interventional Study Evaluating the Quality of Diet in Allogeneic and Autologous Hematopoietic Stem Cell Transplant Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377010
• Other study ID #: IRB201702189
• Secondary ID: UF-BMT-HSCT-001O
• Status: Completed
• Start date: December 14, 2017
• Est. completion date: September 13, 2019

Study information

• Verified date: September 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 13, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic Neoplasm

Intervention

Other:
• Dietary intake -Food Frequency Questionnaire
Dietary intake will be assessed using 2014 full-length food frequency questionnaire. The Block 2014 questionnaire combines a full-length food frequency questionnaire with a brief physical activity screening tool. The food and beverage list includes 127 items in the past 1 month, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.
• Receptivity to Participating in Diet Interventions
Study participants will rate their interest in learning more about dietary interventions to stay healthy using items developed specifically for this study. The items will be rated on a 3-point Likert-type scale from 3 (extremely interested) to 1 (not at all interested).

Locations

Country	Name	City	State
United States	UF Health Cancer Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet intake	To evaluate the diet intake of long-term survivors of HSCT	1 month