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CompletedNCT03377010Updated Sep 17, 2019

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

An observational study in Hematopoietic Neoplasm, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
103
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic Neoplasm
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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No

Groups and cohorts

  • Hematopoietic Stem Cell Transplant (HSCT) Survivor

    Study participants will be administered a Dietary Intake - Food Frequency Questionnaire and a Receptivity to Participating in Diet Interventions Questionnaire.

    Other: Dietary intake -Food Frequency Questionnaire · Other: Receptivity to Participating in Diet Interventions

Interventions

  • OtherDietary 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.

  • OtherReceptivity 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).

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What researchers measure

Primary outcomes

  1. Diet intake

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

    Time frame: 1 month

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Study locations

1 site
  • UF Health Cancer Center
    Gainesville, Florida 32608, United States
07

Registry details

Key details

Study ID
NCT03377010
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Dec 19, 2017
Start date
Dec 14, 2017
Primary completion
Sep 13, 2019
Completion
Sep 13, 2019
Last update
Sep 17, 2019

Study contacts

Nosha Farhadfar, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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