Telephone Counseling - Caregivers for Children with Cancer

描述(申请人提供)：儿童癌症的存活率持续提高，现已接近80%。与此相一致的是，幸存者及其家人的长期健康相关后果是不利的。在整个癌症护理过程中，从确诊到长期存活，儿童及其家人面临着多重和普遍的压力，包括生存机会的不确定性、与治疗有关的不利健康影响、日常活动中断和父母角色功能的中断。这可能会导致临床上严重的全球痛苦、抑郁、创伤后应激(PTS)和自我效能降低。因此，为癌症儿童的父母提供心理社会服务是必要的。然而，可行的、以理论为基础的心理社会干预研究极其有限，特别是在儿童完成癌症治疗的时候，众所周知，这是一个令人焦虑的时期，通常以被遗弃和对未来的不确定性为特征。参与治疗机构面对面干预的障碍包括许多家庭与治疗机构相距甚远，难以离开儿童、家庭或工作，以及治疗机构可能有感官和人际体验而引发焦虑和PTS症状。为了回应这些担忧，我们提议通过设计和实施一种创新的、高度可翻译的基于电话的心理社会干预的小规模可行性试点，将基本心理社会咨询服务的覆盖范围扩大到癌症儿童的主要照顾者。这一干预措施将在从初级主动肿瘤学治疗向后续护理过渡期间实施，这反映了一个被忽视的研究领域。具体地说，我们建议设计并测试一项针对前一年完成癌症治疗的儿童的主要照顾者的心理社会电话咨询计划的两组随机试验的可行性，包括注意控制条件(教育材料和没有咨询的呼唤)和实验条件(电话咨询+教育材料)。我们将评估拟议的电话咨询干预措施的可行性、满意度和感知的帮助。主要的终点将包括心理社会痛苦和利益发现。此外，我们将评估和探索可能解释和阐明干预效果的合理干预机制和途径(中介变量)。将被检验的主要基于理论的中介变量包括次级评价(应对自我效能)和应对努力。最后，基于从这项研究获得的初步数据，我们将寻求资金来设计和实施一项更大规模的随机临床疗效试验，其最终目标将是为癌症儿童的主要照顾者开发一种高效和可输出的电话咨询干预措施，该干预措施可能成为儿童肿瘤患者护理的组成部分。 与公共卫生相关：儿童癌症的存活率现在接近80%，导致幸存者人数不断增加。然而，这种存活可能伴随着对儿童及其父母的重大心理社会挑战，这种挑战可能会在儿童治愈后持续多年。虽然人们对儿童癌症幸存者的心理社会健康有很大的关注，但关于改善他们父母的心理社会健康的研究较少。为了解决这一问题，我们提议设计并进行一项小规模的可行性试点，以创新的基于电话的心理社会干预措施为目标，目标是在孩子癌症治疗完成后的第一年里照顾他们的癌症儿童的主要照顾者，这段时间的特点是对他们孩子的未来感到担忧和焦虑。

DESCRIPTION (provided by applicant): The rate of survival for childhood cancer continues to improve and now approaches 80%. Coincident with this survival are adverse long-term health-related outcomes for survivors and their family members. Throughout the cancer care continuum, from time of diagnosis through long-term survivorship, children and their families are confronted with multiple and pervasive stressors, including uncertainty about the chance of survival, treatment- related adverse health effects, disruption in daily activities and disruption of the parental role function. This may result in clinically significant global distress, depression, posttraumatic stress (PTS) and reduced self-efficacy. Therefore, providing psychosocial services to parents of children with cancer is necessary. Yet, feasible and theory-based psychosocial intervention studies are extremely limited, particularly at the completion of the child's cancer treatment, a time known to be anxiety-provoking and often characterized by feelings of abandonment and uncertainty about the future. Barriers to participation in face-to-face interventions at the treating institution include the considerable distance that many families live from the institution, difficulty leaving children, households or jobs and potential for sensory and interpersonal experiences at the treating institution to trigger symptoms of anxiety and PTS. In response to these concerns, we are proposing to extend the reach of essential psychosocial counseling services to primary caregivers of children with cancer by designing and implementing a small-scale feasibility pilot of an innovative and highly translatable telephone-based psychosocial intervention. This intervention will be implemented during the transition from primary active oncology treatment to follow-up care, reflecting a neglected area of research. Specifically, we propose to design and then test the feasibility of a two-group randomized trial of a psychosocial telephone counseling program for primary caregivers of children who have completed cancer therapy in the previous year, consisting of an attention control condition (educational materials and outcalls with no counseling) and an experimental condition (telephone counseling plus the educational materials). We will evaluate the proposed telephone counseling intervention for feasibility, satisfaction and perceived helpfulness. The primary endpoints will include psychosocial distress and benefit finding. Furthermore, we will assess and explore the plausible intervention mechanisms and pathways that may explain and elucidate intervention efficacy (mediator variables). The main theory-based mediator variables that will be tested include secondary appraisal (coping self-efficacy) and coping effort. Lastly, based on the preliminary data obtained from this study, we will seek funding to design and implement a larger randomized clinical efficacy trial, whose ultimate goal will be to develop a highly effective and exportable telephone counseling intervention for primary caregivers of children with cancer that could be become an integral component of care given to pediatric oncology patients. PUBLIC HEALTH RELEVANCE: Survival from childhood cancer now approaches 80%, resulting in a growing cohort of survivors. However, this survival may be accompanied by significant psychosocial challenges for the children and their parents, which can last for many years after the child is cured. While there has been much focus on the psychosocial well- being of childhood cancer survivors, there is less research on improving the psychosocial well-being of their parents. We are proposing to address this by designing and conducting a small-scale feasibility pilot of an innovative telephone-based psychosocial intervention targeted to primary caregivers of children with cancer in the first year following completion of their child's cancer therapy, a time characterized by concern and anxiety about what the future holds for their child.