Massage Impact on Sleep in Pediatric Oncology

Children's Hospital of Philadelphia70 enrolled

Overview

This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Pediatric Cancer Chemotherapy Effect Acute Myeloid Leukemia Acute Lymphoblastic Leukemia, Pediatric Hematopoietic Stem Cell Transplantation (HSCT)

Interventions

Massage therapyOTHER

Participants in IA will receive a 20-30-minute massage five days per week for 21 days.

Standard of careOTHER

Institutional standard of care treatment

Eligibility

Sex: ALLMin age: 12 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's National Hospital

Washington D.C., District of Columbia, United States

NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Improvement 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.

Time frame: 3 weeks

Secondary Outcomes

Improvement 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).

Time frame: 3 weeks

Central Contacts

Lauren Vernau

CONTACT

267-426-1162 vernaul@chop.edu

Data from ClinicalTrials.gov

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