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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377010
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hematopoietic Neoplasm Other: Dietary intake -Food Frequency Questionnaire Other: Receptivity to Participating in Diet Interventions

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.

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: UF-BMT-HSCT-001: A Non-Interventional Study Evaluating the Quality of Diet in Allogeneic and Autologous Hematopoietic Stem Cell Transplant Survivors
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : September 13, 2019
Actual Study Completion Date : September 13, 2019

Group/Cohort Intervention/treatment
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
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.

Other: 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).




Primary Outcome Measures :
  1. Diet intake [ Time Frame: 1 month ]
    To evaluate the diet intake of long-term survivors of HSCT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377010


Locations
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United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Nosha Farhadfar, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03377010    
Other Study ID Numbers: IRB201702189
UF-BMT-HSCT-001 ( Other Identifier: University of Florida )
OCR16001 ( Other Identifier: Universiy of Florida )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases