Acupressure for Children in Treatment for a Childhood Cancer

AIMS

Aim 1: To assess the benefits and risks of an acupressure intervention plus usual care
compared to usual care alone for children receiving hospital-based treatment for a childhood
cancer. The study hypothesizes that patients in the acupressure arm will report decreased
nausea/vomiting and improved management of cancer-related symptoms compared to usual care
alone. 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 parent anxiety and depression, and increased caregiving self-efficacy 4 weeks
after the end of professional acupressure.

2b. An open-ended question for parents in the intervention arm will elicit information on the
experience of providing acupressure for their children.

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 comparative effectiveness pragmatic
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
hospitalization (continuous) or two months of hospitalization (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 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 and parents in Arm A and Arm B at baseline, three times a week, and
at a once month follow-up.

Inclusion Criteria:

1. Specific eligible disease: Patients must have been diagnosed and be in treatment for a
childhood cancer or a similar disease. Examples of cancers that will be included in
the trial are: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, lymphoma,
rhabdomyosarcoma, osteosarcoma, Hodgkins and Non-Hodgkins Lymphoma, and Pediatric
Brain Tumor (malignant and non-malignant are included since they receive the same
treatments).

2. Adequate number days of hospital-based treatment: Children, adolescents, and young
adults (ages 5-21) are eligible if they will be in treatment for enough days to
receive a regular dose of acupressure and parents can be trained and monitored. This
is defined:

- when a child has an anticipated hospitalization of at least 5 continuous days,
(e.g. BMT, ALL induction, AML) or

- 8 days over 3 weeks (i.e. osteosarcoma patients are typically hospitalized
for 2 days, then one week later, 4-5 days, then again for 2 days equaling >8
days over 3 weeks) or

- children with brain tumors who receive outpatient radiation in the next hospital
building, five days/week for 6 weeks.

3. Inclusion of caregiver: Availability and willingness of a caregiver to deliver
acupressure for children ages 5-17. For young adults ages 18-21 participation of a
parent, or close friend or family member is preferred but not required.

4. Ages 5-21 years' old

5. Parent ability to understand a written informed consent document, and the willingness
to sign it as well as child assent where required. See Table 1 below for age cut-offs.

6. English or Spanish speaking.

7. Admitted to the UCSF Benioff Children's Hospital San Francisco or Oakland site.

Exclusion Criteria:

1. Either the child or the parent has a mental health or medical condition that, in the
opinion of investigators or the treating oncologist, would make it difficult to
participate in the study.

2. Children who do not meet the above criteria.

3. Children who meet the above criteria, but whose treating oncologist advises against
study participation for physical health, mental health (parent or child) or logistical
reasons.