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| Name | Class |
|---|---|
| Scripps Clinic | OTHER |
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This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.
To facilitate rapid randomization and baseline collection of patient samples in the patient's home environment, screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting. The patient will subsequently be contacted by a study investigator to explain the study, including its potential benefits and risks.
Patients meeting all inclusion and exclusion criteria will be randomized 1:1 to receive either educational intervention or standard of care therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Monitoring | No Intervention | Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions. | |
| App-based Educational Intervention | Experimental | The intervention is a pioneering, evidence-based educational program designed to optimize sleep and physical activity outcomes in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based Educational Intervention | Behavioral | The program's educational content is designed to engage patients in the science of sleep and recovery. Segments like "The Sleep Adventure" demystify complex neurobiological processes in an accessible format, aligning with emerging trends in patient education that focus on engagement and knowledge empowerment. Concurrently, the program's physical activity component is meticulously crafted, offering safe, supportive exercises that correspond with the treatment stages of alloHSCT patients. This aspect draws upon evidence highlighting the importance of sustained physical activity during intensive treatments to enhance overall recovery and quality of life. Additionally, the program comprehensively addresses sleep disturbances, prevalent in HSCT patients, through in-depth exploration and evidence-based, non-pharmacologic management strategies, reflecting the significant impact of sleep quality on patient recovery and long-term health outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sleep Measurement | A wearable device will continuously measure objective sleep quality. The outcome will be reported as the average sleep duration (in minutes per day) over the study period. Data will be aggregated for the entire duration of the study. | Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective activity measurement | A wearable device will continuously measure physical activity. The outcome will be reported as the average activity duration (in minutes per day) over the study period. | Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute GVHD | The incidence of acute GVHD will be evaluated through clinical assessment by the treating physician. The outcome will be reported as the number of days from alloHSCT to the onset of acute GVHD. | Monitoring will occur from day of alloHSCT to 100 days post alloHSCT. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jake New, MD, PhD | Contact | 858-784-2701 | new.jacob@scrippshealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jake New, MD, PhD | Scripps Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Health | Recruiting | San Diego | California | 92037 | United States |
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Participants will be randomly assigned to standard of care monitoring or an educational intervention aimed at improving sleep and activity management during the transplantation process.
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| Subjective sleep quality |
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with measurements taken at 12 days prior to hospitalization for alloHSCT, 10 days after alloHSCT, and 60 days after alloHSCT. The PSQI is a validated questionnaire that includes a combination of Likert-type and open-ended questions, which are converted to scaled scores following the PSQI guidelines. Respondents indicate the frequency of specific sleep difficulties over the past month and rate their overall sleep quality. Scores for each component range from 0 to 3. Scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. |
| Measurements will occur 12 days prior to alloHSCT, 10 days after alloHSCT and 60 days after alloHSCT |