Stem Cell Transplant ComplicationsDREAMSNCT06468618
Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
A study testing DREAMS Program Video and Care Kit in people with Stem Cell Transplant Complications and Sleep Disturbance, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Stem Cell Transplant Complications, Sleep Disturbance
- What is being tested?
- DREAMS Program Video and Care Kit
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- -Primary team declines permission to approach.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eric Zhou, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02215
Lucille Lokko, BA, 617-632-6221, lucille_lokko@dfci.harvard.edu
Eric Zhou, PhD, 617-632-6162
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Lucille Lokko, 617-632-6221, lucille_lokko@dfci.harvard.edu
Eric Zhou, PhD
About this study
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.
Read the detailed description
In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.
This is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.
The research study procedures include screening for eligibility and surveys.
Participation in this research study is expected to last for about 2 weeks.
It is expected that about 10 children will take part in this research study.
The American Cancer Society is supporting this research study with grant funding.
- Being tested
- DREAMS Program Video and Care Kit
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAMS Program Video and Care KitBehavioural
A 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.
| Study group | Role | What they receive |
|---|---|---|
| DREAMS Program | Experimental | Enrolled participants and parent(s) will complete:
* Baseline visit with survey
* Standard of care stem cell infusion
* In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit.
* Follow up survey Receives: Behavioral: DREAMS Program Video and Care Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Daily, for 1 week, during the study period.
Program Experience
Open-ended questions regarding what was liked/disliked about the Care Kit materials.
Measured: At Follow-up Assessment Visit (Day 21, up to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start6 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Eric Zhou, PhD, Dana-Farber Cancer Institute
- Investigators
- Eric Zhou, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468618
- Sponsor's protocol ID
- 24-254
- Acronym
- DREAMS
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Fidler AL, Waitt J, Lehmann LE, Solet JM, Duffy JF, Gonzalez BD, Beebe DW, Fedele DA, Zhou ES. Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients. J Hosp Med. 2023 Nov;18(11):999-1003. doi: 10.1002/jhm.13218. Epub 2023 Oct 2.
PubMed 37779507
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT06468618
- Acronym / sponsor ID
- DREAMS / 24-254
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.
This is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.
The research study procedures include screening for eligibility and surveys.
Participation in this research study is expected to last for about 2 weeks.
It is expected that about 10 children will take part in this research study.
The American Cancer Society is supporting this research study with grant funding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DREAMS Program | Experimental | Behavioral: DREAMS Program Video and Care KitEnrolled participants and parent(s) will complete: * Baseline visit with survey * Standard of care stem cell infusion * In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit. * Follow up survey |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- -Primary team declines permission to approach.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DREAMS Program Video and Care KitA 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. | Behavioural | DREAMS Program |
Primary outcome
Enrollment Rate
Time frame: Screening (Day -30 to -1)
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.
Acceptability of Intervention Measure Scale Score
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
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.
DREAMS Care Kit Usage Rate
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Feasibility of the DREAMS Program intervention is defined as ≥50% of participants reporting usage of at least one of the Care Kit materials.
Intervention Assessment Completion Rate
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
Sleep Diary
Time frame: Daily, for 1 week, during the study period.
Program Experience
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 37779507Fidler AL, Waitt J, Lehmann LE, Solet JM, Duffy JF, Gonzalez BD, Beebe DW, Fedele DA, Zhou ES. Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients. J Hosp Med. 2023 Nov;18(11):999-1003. doi: 10.1002/jhm.13218. Epub 2023 Oct 2.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Zhou, PhD contact
Eric Zhou, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DREAMS Program Video and Care Kit in people with Stem Cell Transplant Complications and Sleep Disturbance, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucille Lokko, BA (617-632-6221, lucille_lokko@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Screening (Day -30 to -1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.