Communication and Hospice Online With Optimal Support and Engagement (CHOOSE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 567
- 试验地点
- 1
- 主要终点
- Changes in Patient Health Questionnaire (PHQ-9) score
研究概览
简要总结
The project is a multisite, three-group randomized control trial (RCT) with equal and parallel mixed-methods analysis that allows standardized measures combined with rich qualitative data to test hypotheses and answer research questions. Family caregivers (FCGs) of hospice cancer patients will be recruited and randomized into one of three groups: usual hospice care only (UC), usual care online support group (UCOSG) (without communication strategies), and the CHOOSE intervention group (with communication focus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Eligibility Criteria:
- •Family caregiver of cancer patient receiving hospice care from an affiliated hospice organization. Only 1 FCG per patient may be enrolled.
- •At least 18 years of age.
- •Can speak and understand English.
- •Able to access the internet.
- •Has a Facebook account or is willing to create a Facebook account in order to be in this study
排除标准
- 未提供
研究组 & 干预措施
Usual Care (UC)
Patients randomized to the UC arm will receive the standard of care of intermittent hospice team support.
干预措施: Intermittent Hospice Team Support (Other)
Usual Care Online Social Support (UCOSG)
Patients randomized to the UCOSG arm will have access to an online support group in addition to the standard of care of intermittent hospice team support. The online support group is led by an untrained facilitator.
干预措施: Intermittent Hospice Team Support (Other)
Usual Care Online Social Support (UCOSG)
Patients randomized to the UCOSG arm will have access to an online support group in addition to the standard of care of intermittent hospice team support. The online support group is led by an untrained facilitator.
干预措施: Online Support Group with untrained facilitator (Other)
CHOOSE Intervention
Patients randomized to the CHOOSE intervention will have access to standard of care of intermittent hospice team support and access to an online support group led by a trained facilitator.
干预措施: Intermittent Hospice Team Support (Other)
CHOOSE Intervention
Patients randomized to the CHOOSE intervention will have access to standard of care of intermittent hospice team support and access to an online support group led by a trained facilitator.
干预措施: Online Support Group with trained facilitator (Other)
结局指标
主要结局
Changes in Patient Health Questionnaire (PHQ-9) score
时间窗: Baseline and every 14 days until completion of study (estimated total time 3 months)
The PHQ-9 is a 9-item questionnaire that assesses patient depression. The 9-items are ranked by Likert Scale from 0 - Not at all, 1 - Several days, 2 - More than half the days, and 3 - nearly every day. Scores range from 0-27 with lower scores indicating no or minimal depression and higher scores indicating moderate to severe depression.
Changes in General Anxiety Disorder (GAD-7) score
时间窗: Baseline and every 14 days until completion of study (estimated total time 3 months)
The GAD-7 includes 7-items ranked by Likert scale to measure anxiety severity over the past two weeks. Each item is ranked by 4-point Likert scale as follows: 0-Not at all, 1-Several days, 2-More than half the days, and 3-Nearly every day. Scores range from 0-21, with a higher score indicating higher anxiety.
次要结局
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Well Being Domain Score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in PROMIS Mental Well Being Score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in University of California Los Angeles (UCLA) Loneliness Scale-3 score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Zarit Burden-7 Interview score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Caregiver Quality of Life Index-Revised (CQLI-R) score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Interpersonal Support Evaluation List (ISEL-SF) score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Online Social Support Scale (OSS) score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in The Group Identification Scale (GIS)(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in the Social Disconnectedness Perceived Isolation (SDPI) Social Disconnectedness subscale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Social Disconnectedness Perceived Isolation (SDPI) Perceived Isolation Subscale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Changes in Facebook intensity scale score(Baseline and every 14 days until completion of study (estimated total time 3 months))
- Count of Direct and indirect thread sequences(Throughout timeline of trial (estimated time 3 months))
- Changes in Safety Questions score(Baseline and every 14 days until completion of study (estimated total time 3 months))