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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03377010
Enrollment
103
Registered
2017-12-19
Start date
2017-12-14
Completion date
2019-09-13
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Neoplasm

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.

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).

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diet intake1 monthTo evaluate the diet intake of long-term survivors of HSCT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026