Massage for Pediatric Oncology

Bone Marrow Transplantation Clinical Trial

Official title:

Massage for Children Undergoing Bone Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843180
• Other study ID #: H41337-33343
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: May 2, 2012
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: May 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a pilot randomized controlled feasibility trial of an augmented massage intervention, compared to a usual-care control group, in which intervention group participants will receive up to 3 massage sessions per week, during the 4-6 hospitalization at UCSF for Bone Marrow Transplant (BMT).

Participants will be approximately 24 children recruited from consecutive sample of pediatric cancer and non-cancer patients undergoing BMT age 5 to 18 admitted to UCSF children's hospital during one calendar year.

Intervention: Massage sessions will be gentle Swedish style combine with acupressure and will range from 20-45 minutes, provided by credentialed and trained massage therapists; augmentation will involve massage training for the resident parent, who rooms with the patient, to administer massage to his/her child during the course of the hospital stay. The control group will receive standard-care.

We will collect feasibility data and do exploratory comparison of clinical outcomes between groups.

Knowledge to be gained: We will have preliminary data for a larger trial that will determine whether an augmented massage intervention can support symptom management in the pediatric BMT unit.

B. Hypothesis(es): Briefly explain the hypothesis(es) to be tested. If the study is not designed to test a hypothesis, simply state "None." Hypothesis 1a: >60% of Patients are willing to be randomized to the massage study.

Hypothesis 1b: 80% of patients randomized to massage will accept the massage intervention when offered.

Hypothesis 1c: The majority of parents (>60%) are willing to learn massage techniques for use on their children.

Hypothesis 2a: Professional massage providers will be able to deliver massage, negotiating schedule, space, time, and other patient-related medical activities and will be able to schedule >50% of planned massages.

Hypothesis 2b: Massage providers will be able to assess the acceptable time period for massage (between 10 minutes and 45 minutes).

Hypothesis 2c: Parents will carry out the massage on their children, will do at least 5 massages over the study period and are willing to provide a self-report of estimated time engaged in massage.

Hypothesis 3a: 80% of patients will answer survey questions about their experience in general and the massage intervention.

Hypothesis 3b: The RA will be able to collect clinical data from chart review and electronically stored lab data .

Hypothesis 3c: 80% of parents will answer survey questions about their experience in learning and delivering massage, stress, mood, PTSD symptoms and self-efficacy around patient management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Distress

Intervention

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

Locations

Country	Name	City	State
United States	Childrens' Hospital UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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	No
Secondary	Number of Vomiting Episodes	number of vomiting episodes as reported by nurses per occurence (no upper limit)	day -7 to +21 around transplant date	No
Secondary	Days of Hospital Stay	days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)	days of hospital stay after bone marrow transplant	No
Secondary	Days to Recovery Neutrophil Count	number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)	hospital stay	No