An interventional study of Bright White Light and Dim Red Light in Neoplasms and Fatigue, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Supportive care
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.
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:
SECONDARY OBJECTIVE:
OTHER PRESPECIFIED OBJECTIVES:
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 55 is close to the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days.
Other: Bright White Light
Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days.
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 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
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
Rate of consent
Estimate the rates of consent to a BWL intervention, compared to DRL in adolescent/young adult solid tumor and lymphoma patients.
Time frame: 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.
Time frame: At the end of therapy (Day 60)
Rate of side effects
Estimate rates of side effects in a light therapy intervention trial.
Time frame: At the end of therapy (Day 60)
Rate of fatigue
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).
Time frame: At the end of therapy (Day 60)
Rate of adherence by participant location
Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.
Time frame: At the end of therapy (Day 60)
Rate of depressive symptoms
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.
Time frame: Baseline (Day 0), and approximately Day 14, Day 28 Day 42, and Day 60
Metrics of quality of life and well-being
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).
Time frame: Baseline (Day 0), and approximately Day 14, Day 28, Day 42, and Day 60
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital