Sleep, Stem Cell Transplant Complications
Conditions
Brief summary
Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.
Detailed description
Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant. Objectives: Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery. Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit. Study Design: Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14. Setting/Participants: Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP) Study Interventions and Measures: Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night. Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.
Interventions
BEHAVIORALExtended time between vitals check
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Sponsors
Rutgers University
NJ Dept of Health Commission on Cancer Research
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
actigraphy scoring will be conducted by study staff blind to patient study arm
Intervention model description
Aggregated N of 1 design (ABA or AAB)
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females age 8 to 21 years. 2. Undergoing HSCT at The Children's Hospital of Philadelphia 3. Parent/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
1. History of developmental delays given the relationship to sleep/wake patterns 2. Sleep disorder diagnosis as documented in the medical record 3. Cognitive delays that impact the ability to complete study measures 4. Not proficient in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability Questionnaire | 15 days after transplant | Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement. |
| Parent Acceptability Questionnaire | 15 days after transplant | Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement. |
| Nurse Acceptability Questionnaire | 15 days after transplant | Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement. |
| Health-related Quality of Life (HRQL) | 15 days after transplant | Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy Total Sleep Time | Day of the transplant through 15 days after the transplant | This will measure the total amount of time the subject sleeps each day in minutes. |
| Actigraphy Awakenings-minutes Per Day | Day of the transplant through 15 days after the transplant | This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day. |
| Actigraphy Sleep Efficiency | Day of the transplant through 15 days after the transplant | Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation-Intervention-Observation 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks
Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours) | 29 |
| Observation-Observation-Intervention 5 days of observation, 5 more days of observation, 5 days of extended vitals check
Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours) | 21 |
| Total | 50 |
Baseline characteristics
| Characteristic | Observation-Intervention-Observation | Observation-Observation-Intervention | Total |
|---|---|---|---|
| Age, Continuous | 14.38 years STANDARD_DEVIATION 3.5 | 13.62 years STANDARD_DEVIATION 3.69 | 14.06 years STANDARD_DEVIATION 3.58 |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 13 Participants | 25 Participants |
| Region of Enrollment United States | 29 participants | 21 participants | 50 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 18 Participants | 8 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 21 |
| other Total, other adverse events | 0 / 29 | 0 / 21 |
| serious Total, serious adverse events | 0 / 29 | 0 / 21 |
Outcome results
Primary
Health-related Quality of Life (HRQL)
Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning.
Time frame: 15 days after transplant
Population: 40 participants who completed the study completed this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Health-related Quality of Life (HRQL) | 76.22 units on a scale | Standard Deviation 17.13 |
| Observation-Observation-Intervention | Health-related Quality of Life (HRQL) | 72.02 units on a scale | Standard Deviation 13.48 |
Primary
Nurse Acceptability Questionnaire
Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Time frame: 15 days after transplant
Population: 40 patients completed the full study, this is data reported by nurses about those 40 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Nurse Acceptability Questionnaire | 3.89 units on a scale | Standard Deviation 0.96 |
| Observation-Observation-Intervention | Nurse Acceptability Questionnaire | 3.98 units on a scale | Standard Deviation 0.9 |
Primary
Parent Acceptability Questionnaire
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Time frame: 15 days after transplant
Population: 40 patients completed the study, but not all patients had a parent participate, thus the total number of parents reporting data is 37
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Parent Acceptability Questionnaire | 4.15 units on a scale | Standard Deviation 0.89 |
| Observation-Observation-Intervention | Parent Acceptability Questionnaire | 3.88 units on a scale | Standard Deviation 1.23 |
Primary
Patient Acceptability Questionnaire
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Time frame: 15 days after transplant
Population: 40 patients completed the full study and reported on acceptability at day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Patient Acceptability Questionnaire | 3.63 units on a scale | Standard Deviation 1.61 |
| Observation-Observation-Intervention | Patient Acceptability Questionnaire | 3.55 units on a scale | Standard Deviation 1.46 |
Secondary
Actigraphy Awakenings-minutes Per Day
This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day.
Time frame: Day of the transplant through 15 days after the transplant
Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Actigraphy Awakenings-minutes Per Day | 122.44 minutes per day | Standard Deviation 100.21 |
| Observation-Observation-Intervention | Actigraphy Awakenings-minutes Per Day | 108.94 minutes per day | Standard Deviation 96.66 |
Secondary
Actigraphy Sleep Efficiency
Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed.
Time frame: Day of the transplant through 15 days after the transplant
Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Actigraphy Sleep Efficiency | 74.63 percentage of time in bed spent asleep | Standard Deviation 19.02 |
| Observation-Observation-Intervention | Actigraphy Sleep Efficiency | 80.56 percentage of time in bed spent asleep | Standard Deviation 16.64 |
Secondary
Actigraphy Total Sleep Time
This will measure the total amount of time the subject sleeps each day in minutes.
Time frame: Day of the transplant through 15 days after the transplant
Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation-Intervention-Observation | Actigraphy Total Sleep Time | 374.43 minutes slept per day | Standard Deviation 150.31 |
| Observation-Observation-Intervention | Actigraphy Total Sleep Time | 474.19 minutes slept per day | Standard Deviation 141.11 |