ACTIVE_NOT_RECRUITING

Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

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

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning. Primary Objective To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL. Secondary Objectives To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL. Exploratory Objectives To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.

Official Title

Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

Quick Facts

Study Start:2023-01-05
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05550948

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
  2. * Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
  3. * 18 years of age or older at time of enrollment.
  4. * 2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
  5. * English language proficiency.
  6. * Access to WiFi.
  7. * Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment.
  1. * Estimated intelligence score less than 80.
  2. * Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
  3. * Major psychiatric condition.
  4. * Alcohol abuse in the past year (AUDIT) \[greater than or equal to 13 for women and greater than or equal to 15 for men\]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
  5. * Drug abuse in the past year (DAST-10) \[ greater than or equal to 3 for women or men\] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
  6. * History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
  7. * Enrolled on another independent cognitive intervention protocol within the last year.
  8. * Female participants who are pregnant or lactating (determined by participant self-report due to the remote nature of this study)
  9. * Tattoo or artificial marking in the area where the device will be positioned.

Contacts and Locations

Principal Investigator

Nicholas Phillips, MD,PhD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Nicholas Phillips, MD,PhD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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 Date2023-01-05
Study Completion Date2026-08

Study Record Updates

Study Start Date2023-01-05
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • ALL
  • Hodgkin Lymphoma
  • Cancer
  • Survivorship