Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
- Conditions
- NeoplasmsFatigue
- Interventions
- Other: Dim Red LightOther: Bright White Light
- Registration Number
- NCT02429063
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dim Red Light Dim Red Light Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days. Bright White Light Bright White Light Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days.
- Primary Outcome Measures
Name Time Method Rate of consent Day 0 Estimate the rates of consent to a BWL intervention, compared to DRL in adolescent/young adult solid tumor and lymphoma patients.
Rate of adherence 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.
Rate of side effects At the end of therapy (Day 60) Estimate rates of side effects in a light therapy intervention trial.
- Secondary Outcome Measures
Name Time Method Rate of fatigue 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).
Trial Locations
- Locations (1)
St . Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States