Memphis, Tennessee 38105


Purpose:

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.


Study summary:

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.


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])


NCT ID:

NCT02429063


Primary Contact:

Principal Investigator
Valerie Crabtree, PhD
St. Jude Children's Research Hospital

Valerie Crabtree, PhD
Phone: 866-278-5833
Email: referralinfo@stjude.org


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38105
United States

Valerie Crabtree, Ph.D
Phone: 866-278-5833
Email: referralinfo@stjude.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.