A Multi-component Non-pharmacological Intervention to Improve Cognitive Outcomes in Hematologic Cancer Survivors
University of Alabama at Birmingham
Summary
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.
Description
The investigators propose using "off-the-shelf" products in a 12-week multicomponent cognitive intervention program to address the cognitive impairment in outpatient hematologic malignancy survivors. The program includes two components: i) A modified ketogenic diet using an exogenous ketogenic supplementation using the KetoCal product (\[https://shop.myketocal.com/product/ketocal-41-lq\]) and ii) online cognitive training using Lumosity program (http://www.lumosity.com/). A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 Exclusion Crite…
Interventions
- BehavioralModified ketogenic diet using an exogenous ketogenic formula
Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
- BehavioralOnline cognitive training
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
Location
- University of Alabama at BirminghamBirmingham, Alabama