Massage Impact on Sleep in Pediatric Oncology

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

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

Treatments: Other: Standard of care; Other: Massage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06892158

24-022048

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control Arm (CA)

Active Comparator group

Description:

Standard of care.

Treatment:

Other: Standard of care

Intervention Arm (IA)

Experimental group

Description:

Massage therapy

Treatment:

Other: Massage therapy