RECRUITING

Diet and Cognitive Training in Hematologic Cancer Survivors

Conditions

Cognitive Impairment Hematologic Malignancy Hematologic Cancer Survivors Blood or Marrow Transplantation Cognitive Training Modified Ketogenic Diet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to examine feasibility of a cognitive intervention program in blood cancer survivors. The main questions it aims to answer are: * is it feasible to combine a ketogenic diet supplementation and online cognitive training in an intervention program * will patients using the combined intervention program have improved cognitive functioning compared to those who don't use it * how long will the intervention programs effects last Participants randomized to the intervention arm will consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks, while waitlist arm functions as a control group and will receive the online cognitive training only after a wait period of 12 weeks. Researchers will compare the intervention and waitlist control groups to see if the intervention improves cognitive functioning.

Official Title

A Multi-component Non-pharmacological Intervention to Improve Cognitive Outcomes in Hematologic Cancer Survivors

Quick Facts

Study Start:2022-11-22

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05708716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult with hematologic malignancy diagnosed at age ≥21 years * Outpatient at least 3 months from completion of blood or marrow transplant (BMT) or at least 6 months from diagnosis for patients not treated with BMT * Evidence of mild-to-moderate cognitive impairment using either the Modified Telephone Interview for Mild Cognitive Impairment (TICS-M) or PROMIS 8a short form raw score = 19 -37 * Have daily access to an internet-connected home computer * Can fluently read and write in English * Can understand and sign the study-specific Informed Consent Form	* History of pre-existing neurological disorder or documented major psychiatric disorder * Significant auditory, visual, or motor impairments * History of color blindness * Participated in neuropsychological intervention within the past 6 months * Evidence of active chronic graft vs. host disease (GvHD) for allogeneic BMT * History of pre-existing metabolic disease * Allergies to soy or milk * Body Mass Index (BMI) ≤20

Inclusion Criteria

Exclusion Criteria

* Adult with hematologic malignancy diagnosed at age ≥21 years
* Outpatient at least 3 months from completion of blood or marrow transplant (BMT) or at least 6 months from diagnosis for patients not treated with BMT
* Evidence of mild-to-moderate cognitive impairment using either the Modified Telephone Interview for Mild Cognitive Impairment (TICS-M) or PROMIS 8a short form raw score = 19 -37
* Have daily access to an internet-connected home computer
* Can fluently read and write in English
* Can understand and sign the study-specific Informed Consent Form

* History of pre-existing neurological disorder or documented major psychiatric disorder
* Significant auditory, visual, or motor impairments
* History of color blindness
* Participated in neuropsychological intervention within the past 6 months
* Evidence of active chronic graft vs. host disease (GvHD) for allogeneic BMT
* History of pre-existing metabolic disease
* Allergies to soy or milk
* Body Mass Index (BMI) ≤20

Contacts and Locations

Study Contact

Noha M Sharafeldin, MD, MSc, PhD

CONTACT

2056382144

nsharafeldin@uabmc.edu

Lindsey Hageman, MPH

CONTACT

2056382139

lihageman@uabmc.edu

Principal Investigator

Noha M Sharafeldin, MD, MSc, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Noha M Sharafeldin, MD, MSc, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-22

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2022-11-22

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Hematologic Cancer Survivors
Blood or Marrow Transplantation
Cognitive Training
Modified Ketogenic Diet

Additional Relevant MeSH Terms

Cognitive Impairment
Hematologic Malignancy