Clinical trial NCT03313193: Acupressure for Children in Treatment for a Childhood Cancer
Official title: Acupressure Intervention to Reduce Treatment-related Symptoms in Children With Cancer or Receiving a Hematopoietic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment-Related Cancer
Keywords: nausea
vomiting
pain
fatigue
depression
anxiety
PTSD-parent
caregiver self efficacy-parent
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Pierre's Birthday Fund
First posted: 2017-10-18
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Children who are either receiving treatment for diagnosis of a childhood cancer (curative or supportive care) or are receiving a chemotherapy-based HSCT. Non-malignant brain central nervous system tumors are considered as a childhood cancer.
2. Ages 5- 24 years old.
3. Be receiving hospital-based treatment (inpatient or outpatient) so that acupressure treatments can be delivered and parents can be trained and monitored.
4. Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-17. For young adults ages 18-24 participation of a parent, close friend or family member/caregiver is preferred but not required.
5. English or Spanish speaking.
6. Receiving treatment at UCSF Benioff Children's Hospital.

Exclusion Criteria

1) Children/young adults who meet the above criteria, but whose treating oncologist, health care provider, or a study investigator advises against study participation for physical health, mental health (parent or child) or logistical reasons.

Primary outcomes:
measure: Decrease in nausea/vomiting severity
timeFrame: past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)
Secondary outcomes:
measure: Decreased nausea (PeNAT)
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased vomiting (Vol, 2016)
timeFrame: 30 days hospitalization (continuous or intermittent over 2 months)
measure: Use of fewer rescue anti-emetics (from Electronic Medical Records)
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Complete control of nausea/vomiting
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased pain interference assessed using the PROMIS Pediatric Pain Interference Scale
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased Pain intensity
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased pain assessed (ages 5-7)
timeFrame: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased fatigue symptoms
timeFrame: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased depression symptoms
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased anxiety
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Increased Well-being
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Fewer overall symptoms assessed using the Symptom Screening in Pediatrics (SSPedi) tool (Tomlinson, 2014)
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased depression symptoms using the PROMIS depression (adult) measure.
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Decreased anxiety assessed using PROMIS anxiety (adult)
timeFrame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
measure: Fewer PTSD symptoms, (PCL-5) (adult)
timeFrame: 1 month after end of 30 days trial enrollment
measure: Increased Caregiver Self-Efficacy (parent)
timeFrame: 1 month after end of 30 day trial enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anne Lown, Dr.P.H.
role: PRINCIPAL_INVESTIGATOR
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