Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
NCT Number: NCT06468618
Acronym: DREAMS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stem Cell Transplant Complications|Sleep Disturbance
Interventions: BEHAVIORAL: DREAMS Program Video and Care Kit
Sponsor: Dana-Farber Cancer Institute
Collaborators: American Cancer Society, Inc.
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-06
Completion Date: 2025-08
Locations: Boston Children&#39;s Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.

Primary Outcome Measures: Enrollment Rate, Defined as the proportion of eligible participants approached by research staff and consent to participate in the study with the cutoff set at ≥30% of eligible participants that are approached and agree to participate., Screening (Day -30 to -1)|Acceptability of Intervention Measure Scale Score, Participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention, on a 5-point scale with options ranging from Completely Agree to Completely Disagree., At Follow-up Assessment Visit (Day 21, up to Day 28)|DREAMS Care Kit Usage Rate, Feasibility of the DREAMS Program intervention is defined as ≥50% of participants reporting usage of at least one of the Care Kit materials., At Follow-up Assessment Visit (Day 21, up to Day 28)|Intervention Assessment Completion Rate, Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment., At Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary Outcome Measures: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire, An 8-item measure used to assess the extent of a child's poor sleep. The minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes., Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)|Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire, An 8-item measure used to assess the extent of the consequences of a child's poor sleep. he minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes., Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)|Sleep Diary, A self-report of a participant's daily sleep patterns, including bedtime and total sleep duration., Daily, for 1 week, during the study period.|Program Experience, Open-ended questions regarding what was liked/disliked about the Care Kit materials., At Follow-up Assessment Visit (Day 21, up to Day 28)