NCT06892158

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
26mo left

Started Jan 2025

Typical duration for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Jan 2025Jul 2028

Study Start

First participant enrolled

January 23, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

March 18, 2025

Last Update Submit

April 13, 2026

Conditions

CancerPediatric CancerChemotherapy EffectAcute Myeloid LeukemiaHematopoietic Stem Cell Transplantation (HSCT)Acute Lymphoblastic Leukemia, Pediatric

Keywords

Stem cell transplant (SCT)Decreased sleep efficiencyPediatric cancer diagnosisCircadian activity rhythm (CAR)

Outcome Measures

Primary Outcomes (1)

  • Change 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.

    3 weeks

Secondary Outcomes (1)

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

    3 weeks

Study Arms (2)

Control Arm (CA)

ACTIVE COMPARATOR

Standard of care.

Other: Standard of care

Intervention Arm (IA)

EXPERIMENTAL

Massage therapy

Other: Massage therapy

Interventions

Massage therapyOTHER

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

Intervention Arm (IA)
Standard of careOTHER

Institutional standard of care treatment

Control Arm (CA)

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Cognitive impairment sufficient to preclude completing questionnaires appropriately
  • Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
  • Previous enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

NeoplasmsLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

MassageStandard of Care

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Tracey Jubelirer, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Vernau

CONTACT

267-426-1162vernaul@chop.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized, two-group design (intervention arm, IA and control arm, CA).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 24, 2025

Study Start

January 23, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(2)