Acupressure Intervention to Reduce Treatment-related Symptoms in Children With Cancer or Receiving a Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Decrease in nausea/vomiting severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Ages 5- 24 years old.
- •Be receiving hospital-based treatment (inpatient or outpatient) so that acupressure treatments can be delivered and parents can be trained and monitored.
- •Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-
- •For young adults ages 18-24 participation of a parent, close friend or family member/caregiver is preferred but not required.
- •English or Spanish speaking.
- •Receiving treatment at UCSF Benioff Children's Hospital.
- •Exclusion Criteria
- •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.
排除标准
- 未提供
研究组 & 干预措施
Arm A
Acupressure for Children in Treatment for a Childhood Cancer + usual care
干预措施: Acupressure for Children in Treatment for a Childhood Cancer (Other)
Arm B
Usual care alone
结局指标
主要结局
Decrease in nausea/vomiting severity
时间窗: past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)
assessed using the Pediatric Nausea Assessment Tool (PeNAT)(Dupuis, 2006)(see description below) + a single Question on vomiting for ages 5-17. The MASCC Anti-emesis Tool (MAT) will be used to assess nausea (yes/no) and severity for ages 18+.This composite measure of nausea/vomiting in the child represents a continuum of nausea/vomiting (range=1-8).
次要结局
- Complete control of nausea/vomiting(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased vomiting (Vol, 2016)(30 days hospitalization (continuous or intermittent over 2 months))
- Decreased pain assessed (ages 5-7)(30 days of hospital-based treatment (continuous or intermittent over 2 months))
- Increased Well-being(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased depression symptoms using the PROMIS depression (adult) measure.(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased Pain intensity(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased fatigue symptoms(30 days of hospital-based treatment (continuous or intermittent over 2 months))
- Decreased anxiety(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased anxiety assessed using PROMIS anxiety (adult)(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased pain interference assessed using the PROMIS Pediatric Pain Interference Scale(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased nausea (PeNAT)(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Use of fewer rescue anti-emetics (from Electronic Medical Records)(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Decreased depression symptoms(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Fewer overall symptoms assessed using the Symptom Screening in Pediatrics (SSPedi) tool (Tomlinson, 2014)(30 days hospital-based treatment (continuous or intermittent over 2 months))
- Fewer PTSD symptoms, (PCL-5) (adult)(1 month after end of 30 days trial enrollment)
- Increased Caregiver Self-Efficacy (parent)(1 month after end of 30 day trial enrollment)
研究者
Anne Lown
E. Anne Lown, Dr.P.H., Associate Adjunct Professor
University of California, San Francisco