Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 9-17 years.
Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.
English speaking child and primary caregiver (parent/guardian).
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
DREAMS Program Video and Care Kit
BehavioralA pediatric, circadian health program comprised of an introductory video to sleep experiences for stem cell transplant recipients, strategies to improve sleep, and a Sleep and Circadian Care Kit which includes ear plugs, a white noise machine, an eye mask, a lightbox, and kit instructions. Actigraph, Fitbit, and tablet will be provided to participant and family.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: DREAMS ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Screening (Day -30 to -1)2
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.
Time frame
At Follow-up Assessment Visit (Day 21, up to Day 28)3
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.
Time frame
At Follow-up Assessment Visit (Day 21, up to Day 28)4
Intervention Assessment Completion Rate
Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment.
Time frame
At Follow-up Assessment Visit (Day 21, up to Day 28)Secondary outcomes
1
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.
Time frame
Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)2
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.
Time frame
Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)3
Sleep Diary
A self-report of a participant's daily sleep patterns, including bedtime and total sleep duration.
Time frame
Daily, for 1 week, during the study period.4
Program Experience
Open-ended questions regarding what was liked/disliked about the Care Kit materials.
Time frame
At Follow-up Assessment Visit (Day 21, up to Day 28)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov