Light Therapy to Increase Energy in Adolescents & Young Adults Newly

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02429063
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 17, 2015
Completion date	May 3, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03826043` - THrombo-Embolic Event in Onco-hematology	N/A
Terminated	`NCT03166631` - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread	Phase 1
Completed	`NCT01938846` - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors	Phase 1
Recruiting	`NCT06058312` - Individual Food Preferences for the Mediterranean Diet in Cancer Patients	N/A
Completed	`NCT03308942` - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants	Phase 2
Recruiting	`NCT06018311` - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads	N/A
Withdrawn	`NCT05431439` - Omics of Cancer: OncoGenomics
Completed	`NCT01343043` - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma	Phase 1
Completed	`NCT01938638` - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer	Phase 1
Recruiting	`NCT05514444` - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)	Phase 1
Recruiting	`NCT02292641` - Beyond TME Origins	N/A
Terminated	`NCT00954512` - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)	Phase 1/Phase 2
Recruiting	`NCT04958239` - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)	Phase 1
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Completed	`NCT01222728` - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting	`NCT06004440` - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting	`NCT05636696` - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue	N/A
Not yet recruiting	`NCT06035549` - Resilience in East Asian Immigrants for Advance Care Planning Discussions	N/A
Recruiting	`NCT06004466` - Noninvasive Internal Jugular Venous Oximetry
Not yet recruiting	`NCT02806557` - Profiling Neutrophil Counts in Patients on Chemotherapy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms