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NCT Number: NCT06892158

Massage Impact on Sleep in Pediatric Oncology

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

Recruiting

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Key information

Conditions

Cancer Acute Lymphoblastic Leukemia, Pediatric Acute Myeloid Leukemia Chemotherapy Effect Hematologic Diseases Hematopoietic Stem Cell Transplantation (HSCT) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric Cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage therapy

Other

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

Standard of care

Other

Institutional standard of care treatment

Primary outcomes

  1. Change in total sleep minutes

    Time frame: 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 outcomes

  1. Change in sleep quality as demonstrated by circadian activity rhythms (CARs)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Vernau

CONTACT

[email protected]

267-426-1162

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Children's National Research Institute
  • Massage Therapy Foundation

Registry information

Official study title

Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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