Massage Impact on Sleep in Pediatric Oncology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorChildren's Hospital of Philadelphia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Cognitive impairment sufficient to preclude completing questionnaires appropriately

Insufficient knowledge of English or Spanish that would prohibit completing the study instruments

Previous enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Massage therapy

    Other intervention

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

  • Standard of care

    Other intervention

    Institutional standard of care treatment

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control Arm (CA)Active comparator 1 intervention
Group B: Intervention Arm (IA)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
3 weeks

Secondary outcomes

1

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).

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

Massage Therapy Foundation

Collaborator

Children's National Research Institute

Collaborator