Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 11/30/2018 |
| Start Date: | July 17, 2015 |
| End Date: | October 16, 2018 |
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.
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:
- 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.
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.
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])
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Valerie Crabtree, Ph.D
Phone: 866-278-5833
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