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

NCT03377010 | Completed

• 3 other identifiers: IRB201702189UF-BMT-HSCT-001OCR16001
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Diet intake

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

  1 month

Study Arms (1)

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

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.

Hematopoietic Stem Cell Transplant (HSCT) Survivor

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).

Hematopoietic Stem Cell Transplant (HSCT) Survivor

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Cancer Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nosha Farhadfar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: December 14, 2017
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

US (1)