Building Evidence for Effective Palliative/End of Life Care for Teens with Cancer

 描述（由申请人提供）：我们的最终目标是开发一种结构化儿科高级护理计划（pACP）的国际模型，作为从诊断到生命结束的儿科临终关怀（pPCEOL）的一部分。我们建议建立在我们的美国癌症协会资助的试点研究，循证干预，家庭为中心（FACE）ACP青少年癌症（FACE-TC），以测试我们的完整理论模型与青少年癌症年龄14至21岁，现在我们已经证明了可行性和安全性。这项纵向、多地点、随机、临床、双臂、对照试验将让我们知道FACE-TC是否能帮助家庭了解他们的青少年想要什么样的临终关怀，如果有一个不好的结果。我们还将看到，随着时间的推移，对治疗偏好的一致性是否会继续增加，即使选择随着疾病进展而变化。pACP治疗癌症青少年及其家人，也旨在提高患者及其护理人员的生活质量[身体（疲劳、疼痛）、心理（焦虑和抑郁症状）和精神（意义或目的/和平）]。最后，我们将看看FACE-TC家庭是否更有可能完成护理目标和预先指示。我们将探讨护理目标是否与那些在学习期间死亡的年轻人所接受的护理相匹配。我们还将探讨宗教信仰和经验对治疗选择的影响。pACP很重要，因为避免这些对话可能会导致严重的不良后果，例如不适当和不必要的昂贵护理，父母被指控忽视，法庭诉讼甚至立法干预。父母保护子女和做一个好父母的愿望可能会使家庭四分五裂，而不是加强。FACE-TC是一种文化敏感和适合发展的手动家庭干预措施，以交易压力和应对理论为基础，通过解决问题为二人组（青少年/家庭）做出临终决策做好准备。我们将从两个基于医院的姑息治疗项目中招募受试者，并以2：1的比例（N=260例受试者）将130对受试者随机分配至FACE-TC干预组（N=87对受试者）或作为药物对照的治疗组（N= 43对受试者）。精神状态受损、严重抑郁、有自杀倾向或凶杀倾向或处于寄养状态的参与者将不允许参与。每周将与认证访谈员进行三次60至90分钟的会议：FACE-TC：会议1：里昂预先护理计划调查（c）-青少年和代理版本;会议2：尊重选择访谈（r）;会议3：完成五个愿望（c）。对照组将接受治疗和预先护理计划的信息手册。将在基线和干预后3、6、12和18个月进行结局评估。增长混合模型（GMM）将评估结果。

 DESCRIPTION (provided by applicant): Our ultimate goal is to develop an international model of structured pediatric advance care planning (pACP), as part of pediatric palliative care at end of life (pPCEOL) from the time of diagnosis to the end of life. We propose building on our American Cancer Society funded pilot study, evidence-based intervention, the Family Centered (FACE) ACP for teens with cancer (FACE-TC), to test our full theoretical model with adolescents with cancer ages 14 up to 21, now that we have demonstrated feasibility and safety. This longitudinal, multi-site randomized, clinical, 2-arm, controlled trial will let us kno if FACE-TC helps families to understand what their teens would want for their own end-of-life care, if there was a bad outcome. We will also see if the increased agreement about treatment preferences continues over time, even if the choices change with disease progression. pACP with adolescents with cancer and their families is also aimed at enhancing quality of life [physical (fatigue, pain), psychological (symptoms of anxiety and depression), and spiritual ( meaning or purpose/peace)] for both patients and their caregivers. Finally, we will see if FACE-TC families are more likely to complete goals of care and advance directives. We will explore whether or not goals of care match care received for those young people who die while on study. We will also explore the influence of religious beliefs and experiences on treatment choices. pACP is important because avoiding these conversations may contribute to serious adverse consequences such as inappropriate and unwanted costly care, parents being charged with neglect, court battles and even legislative intervention. Families may be torn apart, rather than strengthened by parents' desire to protect their children and to be a good parent. FACE-TC is a culturally sensitive and developmentally appropriate, manualized family intervention based on transactional stress and coping theory, which prepares the dyad (adolescent/family) for end-of-life decision-making through problem solving. We will recruit from two hospital-based palliative care programs and randomize 130 dyads at a ratio of 2:1 (N=260 subjects) to either FACE-TC Intervention (N=87 dyads) or Treatment as Usual Control (N= 43 dyads). Participants with impaired mental status, severe depression, suicidality or homicidality or in foster care will not be allowed to participate. Three 60- to 90-minute sessions will be conducted with a certified interviewer at weekly intervals: FACE-TC: Session 1: Lyon Advance Care Planning Survey(c) - Adolescent and Surrogate Versions; Session 2: The Respecting Choices Interview(r); Session 3: Completion of The Five Wishes(c). Control will receive Treatment as Usual and an informational booklet on advance care planning. Outcome assessment measures will be administered at baseline, and 3, 6, 12 and 18 month post intervention. Growth mixture modeling (GMM) will assess outcomes.