Group Meaning-Centered Psychotherapy for Caregivers of Patients With Serious Life-Limiting Illness
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention
研究概览
简要总结
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer or a serious life-limiting illness. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual well-being, and mood in caregivers of patients with advanced cancer or a serious life-limiting illness.
详细描述
PRIMARY OBJECTIVES:
I. Determine feasibility as measured by total number of caregivers enrolled in 2 years (modification to extend study another year), adherence (75% of the enrolled participants will complete at least 6 of the 8 MCP groups).
II. Determine acceptability as measured by satisfaction with the research process, as measured by the Was It Worth It (WiWi 2.0) questionnaire.
III. To evaluate preliminary efficacy of group MCP-C for personal meaning as measured by Life Attitude Profile-Revised (LAP-R), spiritual wellbeing as measured by Functional Assessment of Chronic Illness Therapy (FACIT) Spiritual Well-Being Scale (SWBS), depression and anxiety symptoms as measured by Hospital Anxiety and Depression Scale (HADS), meaning in caregiving as measured by Attitudes Towards Caregiving Scale (ATCS), social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Questionnaire (FSSQ), benefit finding as measured by Benefit Finding Scale (BFS).
IV. Determine participants' perceptions of their experience with the intervention, including potential benefits they experienced, which components had the greatest impact, and whether they would suggest any changes to the intervention.
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
- 是
入选标准
- •Age >= 18 years
- •English fluency
- •No diagnosed severe cognitive impairment
- •Caregiver of a patient with a diagnosis of advanced, solid tumor cancer (stage III/stage IV), caregivers supporting a patient with a serious life-limiting illness
- •Provide written (paper or electronic) informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Patient baseline distress score >= 4/10
- •Have ability to utilize the technology to participate in virtual groups
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
- •Cognitive impairment likely to interfere with participation
研究组 & 干预措施
Supportive Care (MCP-C)
Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.
干预措施: Discussion (Other)
Supportive Care (MCP-C)
Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.
干预措施: Health Promotion and Education (Other)
Supportive Care (MCP-C)
Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.
干预措施: Interview (Other)
Supportive Care (MCP-C)
Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.
干预措施: Questionnaire Administration (Other)
Supportive Care (MCP-C)
Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.
干预措施: Behavioral Counseling (Behavioral)
结局指标
主要结局
Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention
时间窗: Up to 1 year
Feasibility will be measured by numbers and percentages of participant recruitment, enrollment, accrual, and retention of participants in the MCP-C intervention. Findings will be summarized using estimates and corresponding 95% confidence intervals.
Acceptability of MCP-C intervention
时间窗: 4 months (2 months post intervention)
Acceptability will be measured by the Was It Worth It (WIWI) Questionnaire. The WIWI consists of 7 questions, 3 answered with yes/no/uncertain, two answered on a 3-point scale (i.e., improved, stayed the same, or got worse), one open-ended/fill-in-the-blank question, and one yes/no question.
次要结局
- Change in spiritual well-being - FACIT-Sp-12(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Changes in anxiety and depression - HADS(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Change in attitude toward caregiving - ATCS(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Change in perception of social support - Duke-UNC FSSQ(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Change in Cancer Support Source Caregiver-18+ score(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Change in personal meaning - LAP-R(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
- Change in benefit-finding - BFS(Baseline, 8 weeks (post intervention), 4 months (2 months post intervention))
研究者
Natalie S. McAndrew, PhD, RN
Co-Principal Investigator
Mayo Clinic