Light Therapy to Treat Depression in Pediatric Stem Cell Therapy Recipients
NCT Number: NCT06496477
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic Stem Cell Transplant
Interventions: DEVICE: Ayo wearable
Sponsor: St. Jude Children's Research Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2028-01
Locations: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States

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.

Primary Outcome Measures: Depression Efficacy, Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period., Baseline
Secondary Outcome Measures: Magnitude and Temporality of Effect in Depression, Depressive symptoms will be assessed using the PROMIS Ped CAT v2.0 - Depressive Symptoms (Patient and Parent Proxy, though Patient report will be used for stratification and is the primary outcome measure and basis for stratification). Participants meet all eligibility criteria including baseline PROMIS scores of 55 or above will be stratified by these scores and receive weekly re-evaluation through the approximately 4-week study period. Sequential assessments are to determine the magnitude of response and time to effect of the intervention between the treatment and control conditions., Baseline|Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective), PROMIS Ped CAT v2.0 - Fatigue (Patient and Parent Proxy), Baseline|Impact on Sleep Quality", Participants will wear actigraphy devices (the Mini Motion Logger AAM-32) for at least 3 days from day 0 - day 7 ± 3 days post-transplant (baseline sleep measures) and at least 3 days from day 21 - 28 ± 3 days post-transplant. Actigraphy devices will be distributed at day 0 and 21 ± 3 days post-transplant and collected on day 7 and 28 ± 3 days post-transplant by a research team member while completing regularly planned study visits. During the days the device is worn, participants will do so for as much time during each day as possible, with near continuous wear being recommended. The device will collect data regarding the participants sleep minutes, sleep efficiency, defined as the percentage of time in bed spent sleeping, and wake after sleep onset, defined as minutes of awakening during a sleep phase. Data will be compared between participants receiving BL versus DL interventions in our study cohort., 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 Outcome Measures: Impact on Delirium Incidence, Comparison of intervention and control group rates of positive (versus negative) screening scores on the Cornell Assessment of Pediatric Delirium. This is an observational scale completed by the patient's assigned nurse near the end of each nursing shift. While the scale has a cut-off point, and the primary exploratory objective is decreased rate of positive screens (CAPD score ≥9), we will also assess the between group scores as a numeric value with a range of 0 - 32. These assessments will be used to determine any impact of the intervention to reduce positive screening rates or overall scores on the CAPD., observed for the entire duration of the intervention|Participant Perceptions of Light Therapy, An investigator created survey focused on participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits will be given to all participants and/or their caregivers on day 28 ± 3 days post-transplant, and also offered to participants withdrawing from the study who have completed at least 3 light therapy sessions. Additionally, participants and/or their primary caregiver during transplant will be asked to participate in an optional qualitative interview until up to 20 interviews are completed. This interview will be focused on the same topics (perceptions of the acceptability, ease of use, and risks/benefits). This data will be analyzed using both quantitative (survey) and qualitative (interview) methods to provide deeper participant/caregiver insights into these topic areas., day 28 ± 3 days post-transplant|Adherence, The light therapy devices worn from Day 1 to Day 28 ± 3 days post-transplant will automatically collect data on their use, including session initiation and length of use identified by participants opening the device's arms and initiating the session by using the connected electronic application (initiation). End-time of each session is determined by the participant closing the arms of the device, ending the session by the connected electronic application, or reaching the full 30-minute allowable length of each individual session. This maximum duration is enforced by the device manufacturer through programing prior to the devices initial use by each participant., 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.|Adverse Effects, : Data on adverse events, both anticipated and unanticipated, will be screened for at each assessment period. Adverse events which are anticipated to occur and be potentially related to the light therapy exposure include: Headaches, Insomnia, Dry eyes, eye pain, or sensitivity to light, Fatigue, Hypomania, and Irritability., day 7-, 14-, 21-, and 28-days post-HSCT ± 3 days|Potential Confounding Effects, Data on number of visits with mental health providers (psychiatry and, if seen more than once for the universal pre-HSCT assessment, psychology) and exposure to medications with potential effects on mental health, as well as their intended indication will be collected from the patient's medical record. This data will be collected from the time of study enrollment until the last day of the intervention., Data will be collected from chart review covering the entire duration of the intervention