跳至主要内容
临床试验/NCT03565757
NCT03565757已完成不适用

Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer Undergoing Outpatient Chemotherapy

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
26
试验地点
2
主要终点
Mean Satisfaction score at 8 weeks

研究概览

简要总结

This study examines Stress Management and Resilience Training (SMART) for family caregivers (FCG) of patients receiving chemotherapy for advanced cancer to potentially help with the stressful aspects of providing care. All participants will receive the SMART intervention.

详细描述

FCGs experience stress and extensive demands in providing care for those with head and neck cancer. Teaching the principles of mindfulness and compassion to FCGs has the potential to protect their psychological health and well-being. This may allow them to provide effective, compassionate care to patients, which ultimately puts the needs of the patient first.

Mindfulness interventions have demonstrated decreased stress and anxiety, and improved self-compassion for individuals, but entail numerous sessions over several weeks, a barrier for caregivers. The SMART program, a brief mindfulness program, has demonstrated improvements in resilience, anxiety, perceived stress, and mindfulness for healthcare providers and patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary caregiver of patient with advanced head and neck cancer receiving chemotherapy, living with the patient at least 50% of the time during treatment, able to read and speak English, cognitively intact, able to take SMART class within 2 weeks of enrollment

排除标准

  • Self-identified mental health diagnoses, less than 18 years of age, not living with patient at least 50% of the time, unable to read and speak English

结局指标

主要结局

Mean Satisfaction score at 8 weeks

时间窗: Week 8

The Was It Worth It (WiWi) questionnaire measures satisfaction in seven questions. The questions are answered as either "yes, no, or unsure," overall perception of life change and experience, an open-ended response question, and an option to talk with someone about concerns. Positive responses will indicate acceptability; results reported as individual items.

Change in Mean Self Compassion Scale-Short Form Score at 8 weeks

时间窗: Baseline and Week 8

The Self Compassion Scale-Short Form will measure self-compassion. This form includes 12 items that are measured on a 4-point scale from "never" to "very often" with higher score indicating a higher level of perceived stress; some of these items are scored in reverse.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherry S. Chesak

Principal Investigator

Mayo Clinic

研究点 (2)

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