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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

Tracking Information
First Submitted Date December 13, 2017
First Posted Date December 19, 2017
Last Update Posted Date September 17, 2019
Actual Study Start Date December 14, 2017
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2017)
Diet intake [ Time Frame: 1 month ]
To evaluate the diet intake of long-term survivors of HSCT
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors
Official Title UF-BMT-HSCT-001: A Non-Interventional Study Evaluating the Quality of Diet in Allogeneic and Autologous Hematopoietic Stem Cell Transplant Survivors
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
  • 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).
Study Groups/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.
Interventions:
  • Other: Dietary intake -Food Frequency Questionnaire
  • Other: Receptivity to Participating in Diet Interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2019)
103
Original Estimated Enrollment
 (submitted: December 13, 2017)
300
Actual Study Completion Date September 13, 2019
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03377010
Other Study ID Numbers IRB201702189
UF-BMT-HSCT-001 ( Other Identifier: University of Florida )
OCR16001 ( Other Identifier: Universiy of Florida )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Nosha Farhadfar, MD University of Florida
PRS Account University of Florida
Verification Date September 2019