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Massage Impact on Sleep in Pediatric Oncology

NCT06892158 · Children's Hospital of Philadelphia
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Official title
Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
About this study
Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments. This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.
Eligibility criteria
Inclusion Criteria: 1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication 2. Expected to be an inpatient for at least 21 days 3. Aged 12 to 21 years at enrollment. 4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP). Exclusion Criteria: 1. Cognitive impairment sufficient to preclude completing questionnaires appropriately 2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments 3. Previous enrollment
Study design
Enrollment target: 70 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-01-23
Estimated completion: 2028-07
Last updated: 2026-04-15
Interventions
Other: Massage therapyOther: Standard of care
Primary outcomes
  • Change in total sleep minutes (3 weeks)
Sponsor
Children's Hospital of Philadelphia · other
With: Massage Therapy Foundation, Children's National Research Institute
Contacts & investigators
ContactLauren Vernau · contact · vernaul@chop.edu · 267-426-1162
InvestigatorTracey Jubelirer, MD · principal_investigator, Children's Hospital of Philadelphia
All locations (2)
Children's National HospitalNot Yet Recruiting
Washington D.C., District of Columbia, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Massage Impact on Sleep in Pediatric Oncology · TrialPath