Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support
研究概览
简要总结
The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication.
详细描述
This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to an attention control comparator. The chaplain intervention will consist of 4 spiritual care visits with a board-certified or board-eligible chaplain once a week for approximately 4 weeks. The attention control comparator will consist of 4 informational support visits with a trained social worker once a week for approximately 4 weeks.
Participants will be randomized 1:1 to the chaplain-led intervention or the attention control comparator.
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
- Single (Outcomes Assessor)
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
- •≥ 18 years old at the time of informed consent
- •Ability to provide informed consent and HIPAA authorization
- •Subject is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung or gastrointestinal (GI) malignancy and receiving cancer care at IU Simon Cancer Center, other IU Health Oncology Clinics, or Eskenazi Health Oncology Clinics
- •Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain
- •Eastern Cooperative Oncology Group (ECOG) score ranging from 0 (fully active) to 3 (able to conduct limited self-care in bed or chair more than 50% of waking hours)
- •Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp
- •Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening
排除标准
- •Subject makes 3 or more errors on the Callahan 6-item cognitive screener administered during screening, or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, intellectual disability, active psychosis) that in the judgment of the research team would preclude providing informed consent and study participation
- •Currently receiving hospice care Note: subjects who enroll in hospice during the trial will have the option of continuing trial participation
- •Have had a visit with a healthcare chaplain within the past 3 months
研究组 & 干预措施
Spiritual Care
Eligible and consented patients randomly assigned to the spiritual care intervention will receive a total of 4 visits with a board-certified or board-eligible chaplain. The intervention will utilize the Spiritual Care Assessment and Intervention (SCAI) framework. These visits will occur weekly for approximately 4 weeks either by telephone or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.
干预措施: Spiritual Care (Behavioral)
Informational Support
Eligible and consented patients randomly assigned to the Informational Support comparator will receive 4 visits with a trained social worker. The comparator intervention will include discussion of topics including quality of life, financial resources, and evaluating health information. These visits will be conducted weekly for approximately 4 weeks. Each visit will take place for approximately 30 minutes.
干预措施: Informational Support (Behavioral)
结局指标
主要结局
Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support
时间窗: Visits 1-4, approximately weekly, within 3 months of enrollment
Percentage of participants 1) enrolling; 2) completing 3 or more intervention sessions; 3) completing all study interviews
Evaluation of acceptability of the Spiritual Care Assessment and Intervention (SCAI) framework vs informational support
时间窗: Visits 1-4, approximately weekly, within 3 months of enrollment; survey 1-week post-intervention
Acceptability Intervention Measure (AIM) This 4-item scale was developed as part of the Consolidated Framework for Implementation Research (CFIR) to evaluate intervention acceptability. Each item is rated on a 5-point scale, ranging from 1 (completely disagree) to 5 (completely agree). Responses are averaged to create a scale score. Higher scores indicate greater acceptability. This is a primary outcome for patients.
Test the effects of spiritual care on the outcome of spiritual wellbeing
时间窗: 1, 6, and 12 weeks post intervention
Measured by the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp): Spiritual wellbeing will be assessed using the Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) 12-item measure. Each item is rated when considering the past week on a scale from 0 (not at all) to 4 (very much). Scores are the sum of individual items with total scores ranging from 0 to 48. Higher scores indicate higher spiritual well-being. This is a primary outcome for patients.
次要结局
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping(1, 6, and 12 weeks post intervention)
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care(1, 6, and 12 weeks post intervention)
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect(1, 6, and 12 weeks post intervention)
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety(1, 6, and 12 weeks post intervention)
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression(1, 6, and 12 weeks post intervention)
- Effects of Spiritual Care Assessment and Intervention (SCAI) framework on meaning and purpose(1, 6, and 12 weeks post intervention)
研究者
Shelley Johns
Associate Professor of Medicine, Research Scientist, Walther Scholar in Psycho-Oncology
Indiana University