Cultural Adaptation of a Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Overall accrual
研究概览
简要总结
This clinical trial develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis.
详细描述
PRIMARY OBJECTIVES:
I. Systematically and culturally adapt a mindfulness-based intervention to improve psychological wellbeing in Latino patients with advanced cancer and their family caregivers.
II. Evaluate the feasibility of the adapted mindfulness-based intervention and overall study procedures in Latino patient-family caregiver dyads.
SECONDARY OBJECTIVE:
I. Determine the effects of the adapted mindfulness-based intervention on the secondary outcomes of patient and caregiver psychological distress, quality of life (QOL), and patient cancer symptoms, compared to a waitlist control.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a stage III-IV solid tumor
- •On active treatment
- •Self-identify as Hispanic/Latino
- •ECOG (Eastern Cooperative Oncology Group) performance status of =< 2
- •Willing to participate in the study with a family caregiver (e.g., spouse, adult child) with whom they currently reside and who consents to participate
排除标准
- •At least 18 years old
- •Able to speak English or Spanish
- •Have access to the internet
- •Able to provide informed consent
研究组 & 干预措施
Group I (mindfulness program)
Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Mindfulness Relaxation (Behavioral)
Group I (mindfulness program)
Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group I (mindfulness program)
Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Questionnaire Administration (Other)
Group I (mindfulness program)
Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Group II (mindfulness waitlist) (Other)
Group II (mindfulness program)
Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Mindfulness Relaxation (Behavioral)
Group II (mindfulness program)
Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group II (mindfulness program)
Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Questionnaire Administration (Other)
Group II (mindfulness program)
Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
干预措施: Group II (mindfulness waitlist) (Other)
结局指标
主要结局
Overall accrual
时间窗: Up to 12 weeks
Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Adherence
时间窗: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Acceptability
时间窗: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Attrition
时间窗: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
次要结局
- Patient and caregiver psychological distress(At 6 and 12 weeks)
- Quality of life questionnaire(At 6 and 12 weeks)
- Patient cancer symptoms(At 6 and 12 weeks)