About this trial
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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).
Disqualifiers
Cognitive impairment sufficient to preclude completing questionnaires appropriately
Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
Previous enrollment
Trial design
Parallel
Treatments tested in this trial
Massage therapy
Other interventionParticipants in IA will receive a 20-30-minute massage five days per week for 21 days.
Standard of care
Other interventionInstitutional standard of care treatment
Treatment groups
Trial outcomes
Primary outcomes
Change in total sleep minutes
Change in the total number of sleep minutes over time in the standard of care intervention compared to the change in the total number of sleep minutes over time in the massage therapy intervention. Sleep minutes are measured by actigraphy.
Secondary outcomes
Change in sleep quality as demonstrated by circadian activity rhythms (CARs)
Amount of dysrgulation in CARs in the standard of care intervention compared to the amount of dysregulation in CARs in the massage therapy intervention. Dysregulation in CARs will be measured by actigraphy (24-h autocorrelation).
Sponsors and contacts
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Children's Hospital of Philadelphia
Lead sponsor
Massage Therapy Foundation
Collaborator
Children's National Research Institute
Collaborator