Massage for Pediatric Oncology
Condition: Bone Marrow Transplantation; Distress
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): massage
Intervention type(s): Other
Intervention description(s): one to three massages per week by massage practitioner additional massages by resident parent who is being taught to massage her/his child
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bone Marrow Transplant; Massage; Pediatric Oncology; children undergoing bone marrow transplantation