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| ID | Type | Description | Link |
|---|---|---|---|
| DCHS20PPR006 | Other Grant/Funding Number | NJ Dept of Health Commission on Cancer Research |
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| Name | Class |
|---|---|
| Rutgers University | OTHER |
| NJ Dept of Health Commission on Cancer Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation-Intervention-Observation | Experimental | 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks |
|
| Observation-Observation-Intervention | Experimental | 5 days of observation, 5 more days of observation, 5 days of extended vitals check |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended time between vitals check | Behavioral | Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days after transplant |
| 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. | 15 days after transplant |
| 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. | 15 days after transplant |
| 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. | 15 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of the transplant through 15 days after the transplant |
| Actigraphy Total Sleep Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lamia Barakat, PhD | CHOP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38197636 | Result | Daniel LC, Venella KL, Woodard K, Poliakova P, Gross JY, Bercovitz IN, Moore D, Barakat LP, Freedman JL. Can extending time between vital sign checks improve sleep in hematopoietic stem cell transplant patients? Testing feasibility, acceptability, and preliminary efficacy. Pediatr Blood Cancer. 2024 Apr;71(4):e30832. doi: 10.1002/pbc.30832. Epub 2024 Jan 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Observation-Observation-Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 40 patients completed the full study and reported on acceptability at day 15 | Posted | Mean | Standard Deviation | units on a scale | 15 days after transplant |
|
During the 15 day study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Daniel | Rutgers University Camden | 856-225-6535 | lauren.daniel@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2022 | Feb 1, 2024 | Prot_SAP_000.pdf |
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Aggregated N of 1 design (ABA or AAB)
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actigraphy scoring will be conducted by study staff blind to patient study arm
This will measure the total amount of time the subject sleeps each day in minutes. |
| Day of the transplant through 15 days after the transplant |
| Actigraphy Awakenings-minutes Per Day | This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day. | Day of the transplant through 15 days after the transplant |
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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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) |
|
|
| 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. | 40 patients completed the study, but not all patients had a parent participate, thus the total number of parents reporting data is 37 | Posted | Mean | Standard Deviation | units on a scale | 15 days after transplant |
|
|
|
| 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. | 40 patients completed the full study, this is data reported by nurses about those 40 patients | Posted | Mean | Standard Deviation | units on a scale | 15 days after transplant |
|
|
|
| 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. | 40 participants who completed the study completed this measure | Posted | Mean | Standard Deviation | units on a scale | 15 days after transplant |
|
|
|
| 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. | 27 of 40 patients who completed the study had evaluable actigraphy data, presented here | Posted | Mean | Standard Deviation | percentage of time in bed spent asleep | Day of the transplant through 15 days after the transplant |
|
|
|
| Secondary | Actigraphy Total Sleep Time | This will measure the total amount of time the subject sleeps each day in minutes. | 27 of 40 patients who completed the study had evaluable actigraphy data, presented here | Posted | Mean | Standard Deviation | minutes slept per day | Day of the transplant through 15 days after the transplant |
|
|
|
| Secondary | Actigraphy Awakenings-minutes Per Day | This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day. | 27 of 40 patients who completed the study had evaluable actigraphy data, presented here | Posted | Mean | Standard Deviation | minutes per day | Day of the transplant through 15 days after the transplant |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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) | 0 | 21 | 0 | 21 | 0 | 21 |
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