The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers.
The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers.
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家庭护理人员在管理晚期癌症患者的医疗保健需求和优化其生活质量方面发挥着重要而紧张的作用，从新诊断到生命结束。虽然早期的远程保健姑息治疗已被发现有效地支持家庭照顾者，很少有工作集中在历史上资源不足的人口，特别是非洲裔美国人和农村居民的个人。为了满足这一需求，我们开发并目前正在测试项目ENABLE（教育，培育，建议，在生命结束之前）基石，这是一项由非专业导航员领导的早期姑息治疗指导干预措施，适用于非洲裔美国人和新诊断晚期癌症的农村居民的家庭护理人员。这是一项比较Cornerstone干预与常规治疗的2中心、单盲、混合I型实施有效性试验。基石是一种基于Pearlin压力-健康过程模型的多成分干预措施，其中非洲裔美国人和/或新诊断晚期癌症患者的农村家庭护理人员（目标样本量= 294对）与非专业导航教练配对，并接受一系列六个简短的20-60分钟的远程医疗课程，重点是压力管理和应对，应对技能，获得帮助，自我护理，为未来做准备/提前护理计划。在核心疗程之后，护理人员每月接受一次无限期的随访，直到患者死亡。在基线和每12周收集护理者和患者结局，直至患者死亡（主要结局：24周时护理者的痛苦;次要结局：护理者：生活质量和负担;患者：痛苦、生活质量和医疗保健利用）。执行费用和干预措施的成本效益也在评估之中。如果这种干预措施证明有效，它将产生一个实施准备好的模式，早期姑息治疗支持资源不足的家庭照顾者。基石干预的一个主要设计原则是，每一种护理情况都是独特的，每一位护理人员都面临着不同的挑战，无法使用一刀切的方法来解决。因此，基石聘请精通文化的外行导航教练，他们经过培训，与参与者建立强大的治疗联盟，并根据不同的个人情况定制他们的教练。ClinicalTrials.gov NCT04318886。于2020年3月20日注册。在线版本包含补充材料，可通过10.1186/s13063-022-06305-w获得。
Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer. This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin’s Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20–60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient’s death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient’s death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated. Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances. ClinicalTrials.gov NCT04318886. Registered on 20 March, 2020. The online version contains supplementary material available at 10.1186/s13063-022-06305-w.
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影响因子：
13.8
作者：
Dionne-Odom, J. Nicholas;Ejem, Deborah B.;Bakitas, Marie A.
通讯作者：
Bakitas, Marie A.
影响因子：
3
作者：
Liu, Bian;Kent, Erin E.;Dionne-Odom, J. Nicholas;Alpert, Naomi;Ornstein, Katherine A.
通讯作者：
Ornstein, Katherine A.
DOI：
10.1007/s00520-017-3650-7
发表时间：
2017-08
期刊：
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
影响因子：
--
作者：
Dionne-Odom JN;Demark-Wahnefried W;Taylor RA;Rocque GB;Azuero A;Acemgil A;Martin MY;Astin M;Ejem D;Kvale E;Heaton K;Pisu M;Partridge EE;Bakitas MA
通讯作者：
Bakitas MA
影响因子：
4.7
作者：
Dionne-Odom, J. Nicholas;Azuero, Andres;Bakitas, Marie A.
通讯作者：
Bakitas, Marie A.
影响因子：
7.4
作者：
Connor, KM;Davidson, JRT
通讯作者：
Davidson, JRT