Massage for Pediatric Oncology

NCT00843180 | Completed Results

• 1 other identifier: H41337-33343
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A multi-center study of an intervention using a combination of massage therapy and a laugh cart to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed with results not yet published. There is still a need for independent studies to isolate the effect of massage for clinical outcomes (such as improved nausea and pain control) in children. Furthermore, this study will test the acceptability of an augmented massage intervention. In addition to provider-child massage, the augmented massage intervention includes training of the resident parent to provide additional parent-child massage, to relieve symptoms as needed. The goal of this augmented intervention is the improvement of symptom management in patients and decreased stress and feelings of helplessness in parents. We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to assess the feasibility of a higher-quality study of the effects of massage in this population. Aim 1: Determine the acceptability of a massage intervention for patients and parents on a pediatric bone marrow transplant unit. Aim 2: Explore the logistics of implementing the augmented massage intervention at the bedside offered to consecutive patients over one year's time. Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes, quality of life, and satisfaction, and parental stress and mood to allow sample size calculations for further studies.

Conditions

Bone Marrow Transplantation; Distress

Keywords

Bone Marrow Transplant; Massage; Pediatric Oncology; children undergoing bone marrow transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)

  days of pain \>3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)

  7 days pre to 21 days post transplant = 28 days

Secondary Outcomes (3)

• Number of Vomiting Episodes

  day -7 to +21 around transplant date

• Days of Hospital Stay

  days of hospital stay after bone marrow transplant

• Days to Recovery Neutrophil Count

  hospital stay

Study Arms (2)

massage

EXPERIMENTAL

Other: massage

control

NO INTERVENTION

usual care only as control arm

Interventions

massage OTHER

one to three massages per week by massage practitioner additional massages by resident parent who is being taught to massage her/his child

massage

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being 5 to 18 years old
• Admitted for BMT.
• Rationale: This is a pediatric study for children up to age 18 admitted to the BMT unit. Questionnaires are not designed for children under age 5.

You may not qualify if:

• Parent or child unable to answer questionnaire due to language limitations.
• Rationale: The pilot character of the study with its limited budget does not include instruments in foreign languages, such as Chinese or Spanish. This could be a project for further studies.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Childrens' Hospital UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

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

• Title: Dr. Wolf Mehling, MD
• Organization: UCSF

mehlingw@ocim.ucsf.edu

415-353 9506

Study Officials

• Wolf E Mehling, MD

  University of California, San Francisco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 8, 2012
• Results First Posted: May 2, 2012

Record last verified: 2012-05

Locations

US (1)