Clinical trial NCT06496477: Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
Official title: Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: Depression
Sleep
Fatigue
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 98
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances.

Primary Objective

To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant.

Secondary Objectives

* To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT.
* To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant.
* To evaluate the response of BL therapy versus DL on sleep quality.

Exploratory Objectives

* To compare incidence of positive delirium screenings between those receiving BL therapy versus DL
* To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.

Detailed description: If you decide to be in this study, you will be asked to:

* Complete some surveys before the study begins
* Take more surveys for about 4 weeks
* Wear light therapy glasses for about 30 minutes each day for about 4 weeks
* Wear a wrist monitor every day and night for the 1st and last week of the study to record your motion and sleeping habits.
* Keep a ''sleep diary" where you will mark the times that you sleep while wearing the wrist monitor.
* Complete an optional interview at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Age ≥8 to \<18 years of age at the time of enrollment
* Allogeneic HSCT planned to occur between 7 and 10 days in the future from recruitment
* Patient and/or primary caregiver reads and writes in English or Spanish
* Participant/guardian is willing to sign informed consent
* Optional interview participants must be English speaking
* Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) ≥ 55

Exclusion Criteria:

* Taking photosensitizing medications
* Total blindness / complete lack of light perception bilaterally
* Significant physiological or psychological impairment that interferes with participation
* Any patient that, in the opinion of the primary investigator is not appropriate for the study
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Non-English-speaking participants will not be eligible for the optional qualitative interview
* Baseline self-report of depressive symptoms on the PROMIS® Pediatric Depressive Symptoms v3.0 (PROMIS-PedDepSx) \< 55

Primary outcomes:
measure: Depression Efficacy
timeFrame: Baseline
Secondary outcomes:
measure: Magnitude and Temporality of Effect in Depression
timeFrame: Baseline
measure: Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective)
timeFrame: Baseline
measure: Impact on Sleep Quality"
timeFrame: Actigraphy devices will be worn for at least 3 days from day 0 - day 7 ± 3 days post-transplant and at least 3 days from day 21 - 28 ± 3 days post-transplant
Other outcomes:
measure: Impact on Delirium Incidence
timeFrame: observed for the entire duration of the intervention
measure: Participant Perceptions of Light Therapy
timeFrame: day 28 ± 3 days post-transplant
measure: Adherence
timeFrame: Day 1 to Day 28 ± 3 days post-transplant, once daily, between the hours of 6 AM and 3 PM CST for a period not to exceed 30 minutes.
measure: Adverse Effects
timeFrame: day 7-, 14-, 21-, and 28-days post-HSCT ± 3 days
measure: Potential Confounding Effects
timeFrame: Data will be collected from chart review covering the entire duration of the intervention
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Andrew Elliott, MD
role: PRINCIPAL_INVESTIGATOR
References: