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Completed

NCT Number: NCT03377010

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health Cancer Center

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary intake -Food Frequency Questionnaire

Other

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

Other

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).

Primary outcomes

  1. Diet intake

    Time frame: 1 month

    To evaluate the diet intake of long-term survivors of HSCT

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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