NeoplasmsNCT02429063
Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
A study testing Bright White Light and Dim Red Light in people with Neoplasms and Fatigue, run by St. Jude Children's Research Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- Bright White Light and Dim Red Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2015to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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])
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this 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.
Read the 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.
- Being tested
- Bright White Light, Dim Red Light
- Keywords
- Solid Tumors
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright White LightOther
Also called 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 BWL Litebook® looks identical to the DRL and utilizes 24 white light-emitting diode (LED) lights and does not emit ultraviolet light.
Dim Red LightOther
Also called Litebook®, DRL
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.
| Study group | Role | What they receive |
|---|---|---|
| Bright White Light | Experimental | Participants use the bright white light intervention for 30 minutes upon waking each morning for 60 days. Receives: Other: Bright White Light |
| Dim Red Light | Experimental | Participants use the dim red light intervention for 30 minutes upon waking each morning for 60 days. Receives: Other: Dim Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of consent
Estimate the rates of consent to a BWL intervention, compared to DRL in adolescent/young adult solid tumor and lymphoma patients.
Measured: 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.
Measured: At the end of therapy (Day 60)
Rate of side effects
Estimate rates of side effects in a light therapy intervention trial.
Measured: At the end of therapy (Day 60)
Secondary outcomes (1)
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).
Measured: At the end of therapy (Day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start17 Jul 2015
- Primary completion16 Oct 2018
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Valerie Crabtree, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429063
- Sponsor's protocol ID
- LITE
- Other IDs
- NCI-2015-00679
- Status last verified
- May 2022
- First submitted
- 21 Apr 2015
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crabtree VM, LaRosa KN, MacArthur E, Russell K, Wang F, Zhang H, Pan H, Brigden J, Schwartz LE, Wilson M, Pappo A. Feasibility and Acceptability of Light Therapy to Reduce Fatigue in Adolescents and Young Adults Receiving Cancer-Directed Therapy. Behav Sleep Med. 2021 Jul-Aug;19(4):492-504. doi: 10.1080/15402002.2020.1797744. Epub 2020 Aug 4.
PubMed 32746639
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study
- ClinicalTrials.gov ID
- NCT02429063
- Acronym / sponsor ID
- LITE
- Keywords
- Solid Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of Tennessee
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright White Light | Experimental | Other: Bright White LightParticipants use the bright white light intervention for 30 minutes upon waking each morning for 60 days. |
| Dim Red Light | Experimental | Other: Dim Red LightParticipants use the dim red light intervention for 30 minutes upon waking each morning for 60 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright White LightAlso: Litebook®, BWLThe 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 | Bright White Light |
| Dim Red LightAlso: Litebook®, DRLThe 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 | Dim Red Light |
Primary outcome
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.
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.
Rate of side effects
Time frame: At the end of therapy (Day 60)
Estimate rates of side effects in a light therapy intervention trial.
1 secondary outcome
Rate of fatigue
Time frame: At the end of therapy (Day 60)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 32746639Crabtree VM, LaRosa KN, MacArthur E, Russell K, Wang F, Zhang H, Pan H, Brigden J, Schwartz LE, Wilson M, Pappo A. Feasibility and Acceptability of Light Therapy to Reduce Fatigue in Adolescents and Young Adults Receiving Cancer-Directed Therapy. Behav Sleep Med. 2021 Jul-Aug;19(4):492-504. doi: 10.1080/15402002.2020.1797744. Epub 2020 Aug 4.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Crabtree, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright White Light and Dim Red Light in people with Neoplasms and Fatigue, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of consent (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.