Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean Satisfaction Score
研究概览
简要总结
The purpose of this study is to test a spiritual care intervention for adults with advanced cancer and their caregivers. This intervention will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Participants will be asked to complete questionnaires and participate in 4 sessions with research chaplains.
详细描述
Several studies have shown that cancer affects multiple dimensions of a patient's life as well as the lives of caregivers and others close to the patient who, when faced with life crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the spiritual care of advanced cancer patients while maintaining proper controls in order to investigate its feasibility, acceptability and potential effects on the emotional and spiritual outcomes of advanced cancer patients and their caregivers. This framework will assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and peace, self-worth and identity. Additionally, not only will this study assess acceptability and feasibility of the intervention, it will also track and document coping, satisfaction, anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers following Spiritual Care Assessment and Intervention (SCAI).
Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for adults with advanced cancer and their caregivers.
Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy trial for patients and their caregivers in the outpatient clinic and home setting.
Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping, depression, and anxiety (secondary outcomes)
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
- •Patient is at least 18 years of age.
- •Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung, colorectal, GI neuroendocrine and Hepatobiliary, testicular and esophageal solid malignancy and receiving cancer care at IU Simon Cancer Center.
- •Patient is willing and able to consent, has a reliable phone and willing to participate in 4 sessions of 30 (+/- 5) minutes per session.
- •Patient has a family member or eligible friend considered to be a caregiver and interested in participating in the study.
- •Patient has adequate English fluency for completion of data collection.
- •Family Caregiver (FCG) is at least 18 years of age.
- •Family Caregiver (FCG) has been invited to participate in the trial with a patient who meets eligibility criteria above.
- •Family Caregiver (FCG) is willing and able to consent and to participate in 4 sessions of 30 (+/- 5) minutes per session
- •Family Caregiver (FCG) has adequate English fluency for completion of data collection.
排除标准
- •Patient makes 3 or more errors on a validated 6-item cognitive screener (Appendix A) or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
- •Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
- •Family Caregiver (FCG) exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
结局指标
主要结局
Mean Satisfaction Score
时间窗: 4 weeks
satisfaction score among participants on the satisfaction survey
Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores
时间窗: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months
Rate of enrollment
时间窗: from recruitment to enrollment (i.e. up to 30 days)
number of eligible patients that are consented and enrolled in the trial
Attendance Rate
时间窗: 4 weeks
proportion of participants who attend all four intervention sessions
次要结局
- Intervention Satisfaction Questionnaire score(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
- Percentage of completed baseline surveys(baseline)
- Patient Health Questionnaire Depression Scale (PHQ-8)(baseline, 1 week, 6 weeks, 3 months)
- Brief RCOPE score(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
- Percentage of completed follow up surveys(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
- McGrill Quality of Life Questionnaire score(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
- Generalized Anxiety Disorder Scale Scores(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
- Caregiver Quality of Life Index-Cancer Questionnaire score(baseline, 1-2 weeks after session 4, 6 weeks, 3 months)
研究者
Alexia M. Torke
Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics
Indiana University