NCT02429063

Brief Summary

Fatigue is one of the most consistent and distressing symptoms reported by pediatric oncology patients. The investigators' work has demonstrated that in the period from diagnosis through the initial 8 weeks of treatment, adolescents and young adults with solid tumors experience substantial fatigue that is not related to sleep disruption. Fatigue can contribute to many adverse outcomes including poor treatment adherence, reduced social activities, depressive symptoms, behavior problems, and poorer quality of life. Unfortunately, no definitive intervention to reduce fatigue has been developed for pediatric oncology patients. Investigators propose a study to estimate the feasibility and acceptability of bright light therapy as an intervention to decrease fatigue in adolescents and young adults who are newly diagnosed and receiving treatment for solid tumors, including lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 17, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

April 21, 2015

Last Update Submit

May 3, 2022

Conditions

NeoplasmsFatigue

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (3)

  • Rate of consent

    Estimate the rates of consent to a BWL intervention, compared to DRL in adolescent/young adult solid tumor and lymphoma patients.

    Day 0

  • Rate of adherence

    Estimate the rates of adherence to the intervention in adolescent/young adult solid tumor or lymphoma patients for each group.

    At the end of therapy (Day 60)

  • Rate of side effects

    Estimate rates of side effects in a light therapy intervention trial.

    At the end of therapy (Day 60)

Secondary Outcomes (1)

  • Rate of fatigue

    At the end of therapy (Day 60)

Other Outcomes (3)

  • Rate of adherence by participant location

    At the end of therapy (Day 60)

  • Rate of depressive symptoms

    Baseline (Day 0), and approximately Day 14, Day 28 Day 42, and Day 60

  • Metrics of quality of life and well-being

    Baseline (Day 0), and approximately Day 14, Day 28, Day 42, and Day 60

Study Arms (2)

Bright White Light

EXPERIMENTAL

Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days.

Other: Bright White Light

Dim Red Light

EXPERIMENTAL

Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days.

Other: Dim Red Light

Interventions

Bright White LightOTHER

The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada). The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on. The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field. The BWL Litebook® looks identical to the DRL and utilizes 24 white light-emitting diode (LED) lights and does not emit ultraviolet light.

Also known as: Litebook®, BWL
Bright White Light
Dim Red LightOTHER

The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada). The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on. The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field. The DRL Litebook looks identical to the BWL box and contains red lights rather than white LED lights.

Also known as: Litebook®, DRL
Dim Red Light

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 12 years or older
  • Has initiated treatment as part of an active St. Jude Children's Research Hospital (SJCRH) treatment plan
  • ≤ 30 days post diagnosis of a solid tumor or lymphoma
  • Patient speaks, reads and writes in English or Spanish
  • Potential participant/guardian is willing to sign informed consent

You may not qualify if:

  • Blind or having a history of eye disease including, but not limited to, macular degeneration, or other diagnosed retinal problems
  • Undergone laser corrective eye surgery in the past 30 days
  • Significant physiological or psychological impairment that interferes with participation (e.g., migraines, bipolar disorder, psychosis, seasonal affective disorder)
  • Recently started on anti-depressant medications (past one month for those on Selective Serotonin Reuptake Inhibitors \[SSRI\] and past two months for those started on Monoamine Oxidase Inhibitors \[MAOI\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Crabtree VM, LaRosa KN, MacArthur E, Russell K, Wang F, Zhang H, Pan H, Brigden J, Schwartz LE, Wilson M, Pappo A. Feasibility and Acceptability of Light Therapy to Reduce Fatigue in Adolescents and Young Adults Receiving Cancer-Directed Therapy. Behav Sleep Med. 2021 Jul-Aug;19(4):492-504. doi: 10.1080/15402002.2020.1797744. Epub 2020 Aug 4.

    PMID: 32746639DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Valerie Crabtree, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 29, 2015

Study Start

July 17, 2015

Primary Completion

October 16, 2018

Study Completion

May 3, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

US(1)