Massage Impact on Sleep in Pediatric Oncology | NCT06892158

Studies
Massage Impact on Sleep in Pediatric Oncology

NCT06892158

Sponsor

Children's Hospital of Philadelphia

Status

Recruiting

Last Update Posted

Apr 15, 2026Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

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

Interventions

Massage therapy
Standard of care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2025Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Mar 18, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 15, 2026Actual

Name	Class
Massage Therapy Foundation	OTHER
Children's National Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Conditions Module

Conditions

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

Keywords

Stem cell transplant (SCT)
Decreased sleep efficiency
Pediatric cancer diagnosis
Circadian activity rhythm (CAR)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm (CA)	Active Comparator	Standard of care.	Other: Standard of care
Intervention Arm (IA)	Experimental	Massage therapy	Other: Massage therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Massage therapy	Other	Participants in IA will receive a 20-30-minute massage five days per week for 21 days.	Intervention Arm (IA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change 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).	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lauren Vernau	Contact	267-426-1162		vernaul@chop.edu

Overall Officials

Name	Affiliation	Role
Tracey Jubelirer, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Hospital	Not yet recruiting	Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D015470	Leukemia, Myeloid, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage
D059039	Standard of Care

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided