A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion. Pediatric cancer and its treatment is one of life's most stressful events for children and their parents. Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.
详细描述
PRIMARY OBJECTIVES:
- To determine the feasibility of Yoga for children with cancer and their parents, specifically
- Identify possible required modifications for safe and feasible practice during infusions.
- Obtain recruitment estimates and determine barriers.
- Assess satisfaction.
SECONDARY OBJECTIVES:
- To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:
- Child psychological distress (stress, anxiety).
- Parent psychological distress (stress, anxiety, anger, depression).
- Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).
- Parent-child communication.
- Child physical symptoms.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with Monroe Carell Jr. Children's Hospital.
- •Parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary).
- •Children and Parents: able to speak and understand English, absence of cognitive impairment, and willing to engage in Yoga as part of a dyad.
排除标准
- •CHILDREN: Medical conditions that would prohibit the safe implementation of a Yoga practice
- •PARENTS: Practices Yoga weekly
- •PARENTS: Pregnant or plans to become pregnant during next 3 months
- •CHILDREN AND PARENTS: Unwilling to work as a dyad.
结局指标
主要结局
Retention
时间窗: Up to 2 years
The number of the enrolled child-parent dyads who complete both the self-report assessments required at baseline (T1 - prior to first Yoga session), the Yoga protocol, and the measures at the end-of-infusion (T2 - prior to last Yoga session) will be tallied. The proportion completing will be used to inform the level of over-recruitment required in future studies of efficacy.
Participant satisfaction
时间窗: Up to 2 years
The total number of responses to the 14 satisfaction questions with a rating \> 4 (maximum rating = 7) will be generated for each of the 5 parent participants. It is expected that all participants will exceed that threshold for all questions. If not, frequency distributions will be used to summarize the responses to each of the 14 items to assess which produced the lower ratings. Responses to open-ended questions will be analyzed qualitatively. Findings from both components of the satisfaction survey (program satisfaction and yoga survey) will be used to revise the Yoga protocol as needed.
Modifications
时间窗: Up to 2 years
Will be assessed qualitatively. A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others.
Recruitment
时间窗: Up to 2 years
The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied.
Barriers
时间窗: Up to 2 years
Participants who do not complete the study will be contacted and queried as to the reason for the lack of completion. A tally of the specific barriers will be maintained to determine if particular barriers are encountered more frequently than others. This information will inform possible modifications required to the protocol in future research.
次要结局
- Parent-child communication(Up to 2 years)
- Parent psychological distress(Up to 2 years)
- Child physical symptoms(Up to 2 years)
- Child psychological distress(Up to 2 years)
- Child and parent physiological stress(Up to 2 years)
研究者
Sheila Ridner
Principal Investigator
Vanderbilt-Ingram Cancer Center