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Feasibility of a mobile application for sleep and circadian rhythms in pediatric patients with acute lymphoblastic leukemia and their caregivers

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL164294-01A1
Agency Tracking Number: R41HL164294
Amount: $273,613.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-03-01
Award End Date (Contract End Date): 2024-02-29
Small Business Information
Chantilly, VA 20151-2296
United States
DUNS: 080542557
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (703) 328-0848
Business Contact
Phone: (703) 328-0848
Research Institution
HOUSTON, TX 77030-3411
United States

 Nonprofit College or University

Long-term survival rates for children diagnosed with acute lymphoblastic leukemia (ALL) currently exceed
90%. However, prolonged ALL chemotherapy, which lasts two to three years on average, is associated with
significant fatigue and sleep disturbances in both children and their caregivers. In fact, patients and caregivers
often identify excess fatigue and sleep disturbances as the most distressing symptoms experienced during ALL
treatment. In addition to adversely impacting quality of life during treatment, fatigue and sleep problems may
alter mood, result in long-term cognitive dysfunction, and potentially compromise treatment efficacy. Despite
unfavorable fatigue and sleep being a pervasive problem in children with ALL and their caregivers, effective
intervention options are limited. Therefore, there is a significant unmet clinical need to identify evidence-based,
minimally invasive strategies to intervene and restore circadian rhythmicity in pediatric patients with ALL and
their caregivers. Building upon our previous success developing mobile applications to address cancer-related
fatigue in adult oncology populations, this proposal seeks to adapt a pilot mobile application to track sleep and
circadian rhythms in patients with ALL and their caregivers. While many existing resources provide information
on the importance of sleep duration, few highlight the role of circadian rhythms and light exposure. In particular,
while numerous commercial wearables exist that can track sleep, few if any give personalized
recommendations for how light exposure and other behaviors can be used to improve sleep, especially in
populations that are likely to have highly disrupted sleep. The proposed project will leverage consumer
wearable technology to conduct sleep and circadian analysis for children with ALL for the purposes of
prescribing lighting and behavioral recommendations to help improve sleep in these patients. Moreover, we
propose to extend the analysis and the prescriptions beyond the patients themselves, to their caregivers,
improving outcomes for the entire family. Specifically, this Phase I STTR proposes two aims: 1) we will design
a mobile app for reducing cancer-related fatigue in pediatric patients with ALL and their caregivers using a
patient-centered approach refined with feedback from patient-caregiver dyads, and 2) we will conduct a
usability study in a population of 16 patient-caregiver dyads to assess the feasibility of an app-delivered light
and behavior-based intervention in this population. The results of this Phase I application will provide the
foundation necessary to conduct a Phase II trial to assess the efficacy of the new app to reduce fatigue and
improve sleep quality and duration in a large population of pediatric ALL patients and their caregivers.
Ultimately, we anticipate this line of research will lead to the identification of a feasible, minimally invasive,
effective intervention to address fatigue and sleep issues in this vulnerable population, leading to
improvements in quality of life and outcomes.

* Information listed above is at the time of submission. *

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