Clinical trial NCT02429063: Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
Official title: Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Fatigue
Keywords: Solid Tumors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: University of Tennessee
First posted: 2015-04-29
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This feasibility and acceptability study will assess the rate of consent to, adherence to, and side effects from a therapy study in a randomized trial comparing bright white light (BWL) to dim red light (DRL). Four questionnaires will be distributed to patients and/or their parents, depending upon the questionnaire, to study the fatigue, quality of life, mood symptoms, and side effects of the BWL/DRL intervention in adolescents and young adults being treated for solid tumors, including lymphoma.

PRIMARY OBJECTIVES:

* To estimate the feasibility and acceptability of a BWL intervention compared to a DRL standard comparison group in adolescent/young adult solid tumor and lymphoma patients.

SECONDARY OBJECTIVE:

* To estimate the effect size of this intervention on measures of fatigue in order to design a larger clinical trial of efficacy of a randomized control trial of BWL versus DRL intervention for fatigue in pediatric oncology patients.

OTHER PRESPECIFIED OBJECTIVES:

* Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.
* Estimate rates of depressive symptoms.
* Describe quality of life.

Eligibility criteria: INCLUSION CRITERIA:

* 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

EXCLUSION CRITERIA:

* 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 \[MAOI\])

Primary outcomes:
measure: Rate of consent
timeFrame: Day 0
measure: Rate of adherence
timeFrame: At the end of therapy (Day 60)
measure: Rate of side effects
timeFrame: At the end of therapy (Day 60)
Secondary outcomes:
measure: Rate of fatigue
timeFrame: At the end of therapy (Day 60)
Other outcomes:
measure: Rate of adherence by participant location
timeFrame: At the end of therapy (Day 60)
measure: Rate of depressive symptoms
timeFrame: Baseline (Day 0), and approximately Day 14, Day 28 Day 42, and Day 60
measure: Metrics of quality of life and well-being
timeFrame: Baseline (Day 0), and approximately Day 14, Day 28, Day 42, and Day 60
Locations:
city: Memphis
country: United States
facility: St . Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Valerie Crabtree, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.