Bone Marrow Transplantation Clinical Trial
Official title:
Massage for Children Undergoing Bone Marrow Transplantation
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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