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Completed

NCT Number: NCT02429063

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

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.

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Key information

Conditions

Neoplasms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

Bright White Light

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.

Other names: Litebook®, BWL

Dim Red Light

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.

Other names: Litebook®, DRL

Primary outcomes

  1. Rate of consent

    Time frame: Day 0

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

  2. Rate of adherence

    Time frame: At the end of therapy (Day 60)

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

  3. Rate of side effects

    Time frame: At the end of therapy (Day 60)

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

Secondary outcomes

  1. Rate of fatigue

    Time frame: At the end of therapy (Day 60)

    Estimate the rates of fatigue between the intervention and comparison groups. Fatigue will be measured by self- and parent-report with the 18-item PedsQL™ Multidimensional Fatigue Scale (MFS) that includes three subscales: (1) general fatigue (six items), (2) sleep/rest fatigue (six items), and (3) cognitive fatigue (six items).

Other outcomes

  1. Rate of adherence by participant location

    Time frame: At the end of therapy (Day 60)

    Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.

  2. Rate of depressive symptoms

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

    Mood symptoms will be assessed with the Children's Depression Inventory, 2nd Edition (CDI 2) in participants 8-17 years old and by the BDI-II in participants 18 years of age and older. The CDI 2 is a 27-item self-report measure of depressive symptoms in children ages 7-17.

  3. Metrics of quality of life and well-being

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

    Quality of life will be assessed by self- and parent-report with the PedsQL™ Acute Version [34] that includes 4 subscales: (1) physical functioning (eight items), (2) emotional functioning (five items), (3) social functioning (five items), and (4) school functioning (five items) as well as a total score. The Likert scale and scoring method are identical to the MFS, with higher scores indicating better health-related quality of life. The PedsQL™ will be completed prior to initiation of the intervention, at three time points during the intervention period (14 +/- 3, 28 +/- 3 days, and 42 +/- 3 days) , and at the end of the 60 day intervention/period (days 61-68).

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • University of California, San Diego
  • University of Tennessee

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2022
First posted
Apr 29, 2015
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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