Massage Impact on Sleep in Pediatric Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Massage therapy, Standard of care.
- Who it may be relevant to
- Registry conditions: Cancer, Pediatric Cancer, Chemotherapy Effect, Acute Myeloid Leukemia. Basic parameters: 12 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
Overview
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Detailed description
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.
Interventions
- Other Massage therapy
Participants in IA will receive a 20-30-minute massage five days per week for 21 days. - Other Standard of care
Institutional standard of care treatment
Primary outcome measures
- Change in total sleep minutes [Time frame: 3 weeks]
Secondary outcome measures (1)
- Change in sleep quality as demonstrated by circadian activity rhythms (CARs) [Time frame: 3 weeks]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- Cognitive impairment sufficient to preclude completing questionnaires appropriately
- Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
- Previous enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Children's National Hospital — Washington D.C.
- Children's Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT06892158 · 24-022048