The TOUCH Project: Reducing Distress and Promoting Quality of Life Via Caregiver Massage of Children Undergoing Treatment for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
研究概览
简要总结
This clinical trial studies massage therapy given by caregiver in treating quality of life of young patients undergoing treatment for cancer. Massage therapy given by a caregiver may improve the quality of life of young patients undergoing treatment for cancer
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers.
II. To investigate feasibility of implementing a brief targeted massage training protocol with caregivers.
III. To identify barriers to recruitment, intervention adherence, and full study completion by consented families.
IV. To assess preliminary effectiveness of the massage intervention in reducing caregiver and child psychological distress (anxiety, depression, parenting stress) and promoting child health-related quality of life.
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
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed protocol specific informed consent by the child's caregiver Assent by the child Caregiver is at least 18 years of age The child is currently treated for cancer (chemotherapy alone, radiation therapy alone, chemotherapy and radiation therapy, chemotherapy and surgery, or radiation therapy and surgery) at Wake Forest Baptist Health (WFBH) Pediatric Oncology The child has at least 16 weeks remaining on their treatment regimen The caregiver and child understand written and spoken English The child has no medical or functional contraindications reported by his/her attending\physician
排除标准
- •Parents/caregivers who have previously provided consistent massage for their child will be excluded from the study Child is receiving radiation only
研究组 & 干预措施
Arm I (WAITLIST CONTROL GROUP)
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
干预措施: questionnaire administration (Other)
Arm I (WAITLIST CONTROL GROUP)
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
干预措施: quality-of-life assessment (Procedure)
Arm I (WAITLIST CONTROL GROUP)
Patients and caregivers receive standard of care and are offered the massage intervention after 8 weeks.
干预措施: standard follow-up care (Procedure)
Arm II (TOUCH)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks.
干预措施: massage therapy (Procedure)
Arm II (TOUCH)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks.
干预措施: questionnaire administration (Other)
Arm II (TOUCH)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks.
干预措施: quality-of-life assessment (Procedure)
Arm II (TOUCH)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks.
干预措施: intervention by caregiver (Other)
Arm III (TOUCH+)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist.
干预措施: massage therapy (Procedure)
Arm III (TOUCH+)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist.
干预措施: questionnaire administration (Other)
Arm III (TOUCH+)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist.
干预措施: quality-of-life assessment (Procedure)
Arm III (TOUCH+)
Caregivers undergo a 60-minute training session on simple massage techniques, including the "Massage Toolkit," comprising Swedish Massage and Trigger Point Therapy Massage, at week 0 and a booster 60-minute massage training session at week 4 with a licensed massage therapist. Caregivers are instructed to massage their children for at least 3 20-minute sessions per week for 8 weeks. Caregivers also receive a 45-minute massage by the massage therapist.
干预措施: intervention by caregiver (Other)
结局指标
主要结局
Feasibility and acceptability of conducting a massage intervention with childhood cancer patients and their primary caregivers
时间窗: Up to 16 weeks
次要结局
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life(Week 16)
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life(Baseline)
- Effectiveness of caregiver massage to reduce child and caregiver distress and promote child health-related quality of life(Week 8)