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Massage for Pediatric Oncology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00843180
First received: February 12, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
Results First Received: February 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Bone Marrow Transplantation
Distress
Intervention: Other: massage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
November 2008-November 2009, 12 months UCSF Children's Hospital, Bone Marrow Transplant Unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
consecutive enrollment of all eligible admitted children. 2 teenage boys declined participation

Reporting Groups
  Description
Massage massage and acupressure up to 3x/week for entire hospital stay
Control usual care only as control arm hospital care during bone marrow transplant

Participant Flow:   Overall Study
    Massage     Control  
STARTED     16     7  
COMPLETED     16     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Massage massage and acupressure up to 3x/week for entire hospital stay
Control usual care only as control arm hospital care during bone marrow transplant
Total Total of all reporting groups

Baseline Measures
    Massage     Control     Total  
Number of Participants  
[units: participants]
 		  16     7     23  
Age  
[units: participants]
 		     
<=18 years     16     7     23  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  10.9  ± 3.7     13.7  ± 4.3     11.7  ± 4.0  
Gender  
[units: participants]
 		     
Female     7     3     10  
Male     9     4     13  
Region of Enrollment  
[units: participants]
 		     
United States     16     7     23  



  Outcome Measures
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1.  Primary:   Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)   [ Time Frame: 7 days pre to 21 days post transplant = 28 days ]
  Show Outcome Measure 1

2.  Secondary:   Number of Vomiting Episodes   [ Time Frame: day -7 to +21 around transplant date ]
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3.  Secondary:   Days of Hospital Stay   [ Time Frame: days of hospital stay after bone marrow transplant ]
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4.  Secondary:   Days to Recovery Neutrophil Count   [ Time Frame: hospital stay ]
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  Serious Adverse Events
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Time Frame any adverse events were documented during entire hospital stay, censored at 100 days.
Additional Description Medical records were checked weekly, nurse managers were contacted regularly, attending physicians were ready to inform the research team for any eventual adverse events.

Reporting Groups
  Description
Massage massage and acupressure up to 3x/week for entire hospital stay
Control usual care only as control arm hospital care during bone marrow transplant

Serious Adverse Events
    Massage     Control  
Total, serious adverse events      
# participants affected / at risk     0/16 (0.00%)     0/7 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. small sample size
  2. limited number of time points for self-report assessments.
  3. the dose of the massage intervention averaged 1.8 massages per week, while the target dose was 3 per week.
 


Results Point of Contact:  
Name/Title: Dr. Wolf Mehling, MD
Organization: UCSF
phone: 415-353 9506
e-mail: mehlingw@ocim.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00843180     History of Changes
Other Study ID Numbers: H41337-33343
Study First Received: February 12, 2009
Results First Received: February 7, 2012
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board