Hematopoietic Stem Cell Transplant
Conditions
Keywords
Depression, Sleep, Fatigue
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.
Interventions
DEVICEAyo wearable
Primary study device - the Ayo wearable which are glasses that emit either bright blue-spectrum white light or dim blue-spectrum white light or Mini motion logger AAM-32 - an actigraphy device work during the first and last week of the study on the participants wrist throughout most of the day, measuring activity. This will be used as an indicator of sleep.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Efficacy | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude and Temporality of Effect in Depression | Baseline | 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. |
| Fatigue Efficacy" (though we will also have data for magnitude and temporality given data collection is identical to the primary objective) | Baseline | PROMIS Ped CAT v2.0 - Fatigue (Patient and Parent Proxy) |
| Impact on Sleep Quality" | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Elliott, MD
St. Jude Children's Research Hospital
Outcome results
None listed