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Massage Therapy to Improve Sleep Quality in Hospitalized Pediatric Cancer and Stem Cell Transplant Patients
Trial Status: active
This clinical trial studies whether massage therapy improves sleep quality in hospitalized pediatric cancer and stem cell transplant (SCT) patients. Decreased sleep quality and sleep disturbances are common in children with cancer and are especially troublesome in hospitalized patients. Disturbed sleep has negative health-related consequences and can lead to poor quality of life. Massage therapy is a treatment in which the soft tissues of the body are kneaded, rubbed, tapped, and stroked. Massage therapy may help people relax, relieve stress and pain, lower blood pressure, and improve circulation. It may also be an effective way to improve sleep quality in hospitalized pediatric cancer and SCT patients.
Inclusion Criteria
Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic hematopoietic stem cell transplant (HSCT) for any indication
Expected to be an inpatient for at least 21 days
Aged 12 to 21 years at enrollment
Inpatient at Children’s National or Children’s Hospital of Philadelphia (CHOP)
Exclusion Criteria
Cognitive impairment sufficient to preclude completing questionnaires appropriately
Insufficient knowledge of English or Spanish that would prohibit filling out the instruments
Previous enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT06892158.
I. To determine if a 21 day individualized massage therapy intervention for hospitalized children and adolescents receiving intensive chemotherapy or undergoing SCT, when compared to a control group, is associated with improved sleep and more robust circadian rhythms (CARs).
II. To determine if a 21 day individualized massage therapy intervention for hospitalized children and adolescents receiving intensive chemotherapy or undergoing SCT, when compared to a control group, is associated with improved quality of life (QOL) and reduced burden of symptoms that commonly cluster with poor sleep and dysregulated CAR including: (1) fatigue, (2) anxiety, and (3) pain.
OUTLINE: Patients are randomized to 1 of 2 arms.
INTERVENTION ARM (IA): Patients receive a massage focused on the head, neck, back, hands, and feet over 20-30 minutes once daily (QD), Monday-Friday, for 21 days in the absence of unacceptable toxicity.
CONTROL ARM (CA): Patients receive institutional standard of care (SOC) supportive measures, which may include a massage once a week (QW), for 21 days in the absence of unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationChildren's Hospital of Philadelphia
