Massage Impact on Sleep in Pediatric Oncology

NCT ID: NCT06892158

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2028-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm (CA)

Standard of care.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Institutional standard of care treatment

Intervention Arm (IA)

Massage therapy

Group Type EXPERIMENTAL

Massage therapy

Intervention Type OTHER

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

Interventions

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Massage therapy

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

Intervention Type OTHER

Standard of care

Institutional standard of care treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massage Therapy Foundation

OTHER

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracey Jubelirer, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's National Hospital

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

Site Status NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Vernau

Role: CONTACT

267-426-1162

Facility Contacts

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Catriona Mowbray, PhD

Role: primary

202-476-3723

Tracey Jubelirer, MD

Role: primary

Lauren Vernau

Role: backup

Other Identifiers

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24-022048

Identifier Type: -

Identifier Source: org_study_id

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