Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study

NCT ID: NCT02429063

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-17
• Study Completion Date: 2022-05-03

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.

Conditions

Neoplasms; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bright White Light

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

Group Type: EXPERIMENTAL

Bright White Light

Intervention Type: OTHER

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.

Dim Red Light

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

Group Type: EXPERIMENTAL

Dim Red Light

Intervention Type: OTHER

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.

Interventions

Bright White Light

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.

Intervention Type: OTHER

Dim Red Light

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.

Intervention Type: OTHER

Other Intervention Names

Litebook®; BWL; Litebook®; DRL

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])

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Crabtree, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St . Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32746639 (View on PubMed)

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2015-00679

Identifier Type: REGISTRY

Identifier Source: secondary_id

LITE

Identifier Type: -

Identifier Source: org_study_id