Acute Lymphoblastic Leukemia, Pediatric, Acute Myeloid Leukemia, Cancer, Chemotherapy Effect, Hematopoietic Stem Cell Transplantation (HSCT), Pediatric Cancer
Conditions
Keywords
Stem cell transplant (SCT), Decreased sleep efficiency, Pediatric cancer diagnosis, Circadian activity rhythm (CAR)
Brief summary
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
OTHERMassage therapy
Participants in IA will receive a 20-30-minute massage five days per week for 21 days.
OTHERStandard of care
Institutional standard of care treatment
Sponsors
Children's Hospital of Philadelphia
Massage Therapy Foundation
Children's National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total sleep minutes | 3 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality as demonstrated by circadian activity rhythms (CARs) | 3 weeks | 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). |
Countries
United States
Contacts
CONTACTLauren Vernau
PRINCIPAL_INVESTIGATORTracey Jubelirer, MD
Children's Hospital of Philadelphia
Outcome results
None listed