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个国际模式的结构化儿科先期护理计划(PACP)，作为儿科临终姑息护理(PPCEOL)的一部分，从诊断时到生命结束。我们建议在我们的美国癌症协会资助的试点研究循证干预的基础上，以家庭为中心的青少年癌症ACP(Face-TC)为基础，在14岁至21岁的青少年癌症患者中测试我们的完整理论模型，因为我们已经证明了可行性和安全性。这项纵向、多点随机、临床、双臂对照试验将让我们知道Face-TC是否有助于家庭了解他们的青少年希望自己的临终关怀是什么，如果有糟糕的结果。我们还将观察关于治疗偏好的增加的共识是否会随着时间的推移而持续，即使选择随着疾病的进展而改变。青少年癌症患者及其家人的PACP还旨在提高患者及其照顾者的生活质量[身体(疲劳、疼痛)、心理(焦虑和抑郁症状)和精神(意义或目的/平静)]。最后，我们将看看Face-TC家庭是否更有可能完成护理目标和提前指令。我们将探索护理目标是否与那些在学习期间死亡的年轻人所得到的护理相匹配。我们还将探讨宗教信仰和经历对治疗选择的影响。PACP很重要，因为避免这些对话可能会导致严重的不良后果，如不适当和不必要的昂贵护理，父母被指控疏忽，法庭诉讼，甚至立法干预。家庭可能会四分五裂，而不是因为父母想要保护孩子和做一个好父母的愿望而得到加强。Face-TC是一种基于交易压力和应对理论的文化敏感性和发展适宜性的手工家庭干预，通过解决问题为二人组(青少年/家庭)的临终决策做好准备。我们将从两个基于医院的姑息治疗计划中招募新成员，并按2：1(N=260名受试者)的比例随机选择130名二元组，即面对面-TC干预组(N=87组)或常规对照治疗组(N=43组)。精神状态受损、严重抑郁、自杀或凶残或寄养的参与者将不被允许参加。每周将与经认证的面试者进行三次60至90分钟的面谈：Face-TC：会议1：里昂高级护理计划调查(C)--青少年版和代孕版本；会议2：尊重选择面谈(R)；会议3：完成五个愿望(C)。控制组将一如既往地接受治疗，并编写一本关于提前护理计划的资料手册。结果评估措施将在基线以及干预后3、6、12和18个月进行。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.