Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress
研究概览
简要总结
Researchers are trying to find out if the Resilient Living Program will improve quality of life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and their caregivers.
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
- 否
入选标准
- •for patients:
- •Age ≥18 years
- •English fluency
- •No diagnosed severe cognitive impairment
- •Diagnosis of stage IV solid tumor cancer
- •Expected prognosis >6 <18 months
- •Provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Patient baseline distress score ≥4/10 OR identified as having distress that would benefit from program by care team or provider
- •Ability to do first Resilient Living session in person
- •Inclusion Criteria for caregivers:
- •Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study
- •Provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Age ≥18 years
- •English fluency
- •No diagnosed severe cognitive impairment
- •Ability to do first Resilient Living session in person
排除标准
- •As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded.
- •Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
研究组 & 干预措施
Resilient Living Program
All participants will be in the Resilient Living Program arm. Study participation involves participating in a 12-week stress management and resilience training program. This will involve four virtual sessions (video or phone) and answering questions about their health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.
干预措施: Resilient Living Program (Behavioral)
结局指标
主要结局
Change in Perceived Stress
时间窗: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
Change in Anxiety
时间窗: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
次要结局
未报告次要终点
研究者
Deirdre R. Pachman
Principal Investigator
Mayo Clinic