Acupressure for Children in Treatment for a Childhood Cancer
Condition: Treatment-Related Cancer
MeSH terms: Neoplasms, Second Primary
Study type: Interventional

Summary: 
      Background: Despite advances in symptom management, children undergoing cancer treatment or
      receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from
      moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological
      distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and
      clinicians have expressed interest in including non-pharmacologic approaches to improve
      symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care.
      More evidence is needed from well-designed trials with larger samples and rigorous designs in
      order to make definitive recommendations about the routine inclusion of acupressure among
      pediatric patients being treated for childhood cancer or receiving a HSCT.

      Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1
      into 2 study arms (50 children in each arm). Arm A participants will be offered usual care
      and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver
      will be instructed in acupressure delivery for the child as symptoms arise. Arm B
      participants will receive usual care alone. (At the study end, Arm B parents will be offered
      acupressure instructions.) Children will be enrolled for ~30 days which can occur with one
      month of continuous hospital-based treatment or two months of intermittent hospital-based
      treatment (inpatient or regular outpatient treatment). Parent and child participants will
      receive a follow-up interview one month after completion of the intervention (Arm A) or the
      final symptom assessment (Arm B).

      Significance This is the first study to evaluate the effectiveness and safety of an
      acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment
      for a childhood cancer or receiving a chemo-therapy based HSCT.
    

Detailed description: 
      AIMS

      Aim 1: To assess the feasibility of an acupressure intervention plus usual care and to assess
      the benefits and risks compared to usual care alone for children receiving hospital-based
      treatment for a childhood cancer or a HSCT. The study hypothesizes that patients in the
      acupressure arm will report decreased nausea/vomiting and improved management of treatment
      -related symptoms compared to the usual care only arm. We will test the following hypotheses:

      1a. Primary outcomes: Children receiving acupressure will report reduced nausea/vomiting
      measured as a composite variable compared to the usual care alone group.

      1b. Secondary outcomes: Children receiving the acupressure intervention will have reduced
      levels of each; nausea, vomiting, and rescue antiemetic use compared to the usual care alone
      group.

      1c. Secondary outcomes: Children receiving acupressure will report reduced pain interference
      and pain intensity, reduced fatigue, anxiety, depression, other treatment-related symptoms,
      and greater positive affect compared to the usual care group. Children receiving acupressure
      will use less rescue pain medication compared to the usual care alone group.

        1. d. Greater dose of acupressure will lead to greater improvement of primary and secondary
           outcomes.

           Aim 2: To assess the benefits and challenges of providing the acupressure intervention
           for parents.

        2. a. The parent/caregiver in Arm A will report decreased post-traumatic stress symptoms,
           reduced anxiety and depression, and increased caregiving self-efficacy 4 weeks after the
           end of professional acupressure. 2b. An open-ended question for parents/caregivers in
           the intervention arm will elicit information on the experience of providing acupressure
           for their children.

      Additional Qualitative Aims:

      Qualitative Aim 1: To explore the child's experience of receiving acupressure and the
      caregiver's experience of delivering acupressure to the child through a semi-structured
      interview with the caregiver, with a focus on well-being. We will explore how acupressure
      impacts the proposed components of well- being: hedonistic and eudemonic perspectives of
      positive feelings, as well as the less studied somatic and physical components such as
      mind-body integration and increased connection through touch in the child and caregiver.

      Qualitative Aim 2: To explore the acupressure provider's impression of how provider- or
      caregiver- delivered acupressure impacts the child's experience of childhood cancer treatment
      or HSCT.

      DESIGN The goal of the study is to describe the benefits and risks of an acupressure
      intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a
      control group receiving usual care. This study is a pragmatic randomized clinical trial.
      Participants will be randomized 1:1 into 2 study arms. In Arm A children will be offered
      professional acupressure five times weekly along with usual care for ~30 days of
      hospital-based treatment (continuous in-hospital) or two months of hospital-based treatment
      (intermittent) for an approximate total of 20 semi-standardized acupressure treatments.
      Treatments take approximately 20 minutes each. A parent/caregiver will be instructed in how
      to deliver acupressure to his/her child as symptoms arise using a simplified protocol with
      supplemental educational handouts. In Arm B participants will receive usual care alone. All
      usual care is defined according to COG supportive care guidelines. After the final study
      assessment parents/caregivers will be given instruction on how to deliver acupressure.
      Outcomes will be assessed in all children in Arm A and Arm B at baseline, 5 days a week for
      nausea, vomiting, and pain, two times a week for remaining symptoms, and at a once month
      follow-up. Outcomes will be assessed in caregivers at baseline, ~day 7, and at follow-up.
    

Intervention name(s): Acupressure for Children in Treatment for a Childhood Cancer
Intervention type(s): Other
Intervention description(s): This study will describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. Children in Arm A will receive usual symptom management care + acupressure 5 days/week for ~20 treatments. Parents will be taught how to provide acupressure as well. Children in Arm B will receive usual care alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pragmatic Randomized Controlled Trial
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: nausea; vomiting; pain; fatigue; depression; anxiety; PTSD-parent; caregiver self efficacy-parent