Acupressure for Children in Treatment for a Childhood Cancer (ACT-CC)

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.