Telephone Counseling - Caregivers for Children with Cancer

描述（由申请人提供）：儿童癌症的存活率继续提高，现在接近80%。与此同时，幸存者及其家庭成员的长期健康相关不良后果。在癌症护理的整个过程中，从诊断到长期生存，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、与治疗有关的不良健康影响、日常活动的中断和父母角色功能的中断。这可能会导致临床上显著的全球痛苦，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，可行的和理论为基础的心理社会干预研究是非常有限的，特别是在完成儿童的癌症治疗，一个时间被称为是焦虑的挑衅，往往是被遗弃的感觉和对未来的不确定性的特点。在治疗机构参与面对面干预的障碍包括许多家庭住得离机构相当远，难以离开儿童、家庭或工作，以及在治疗机构的感官和人际体验可能引发焦虑和PTS症状。针对这些问题，我们建议通过设计和实施一项创新的、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范围扩大到癌症儿童的主要照顾者。这种干预措施将在从主要的积极肿瘤治疗过渡到后续护理期间实施，反映了一个被忽视的研究领域。具体来说，我们建议设计，然后测试的可行性的两组随机试验的心理社会电话咨询计划的主要照顾者的儿童已经完成癌症治疗的前一年，包括注意力控制条件（教育材料和出诊没有咨询）和实验条件（电话咨询加上教育材料）。我们将评估建议的电话咨询干预的可行性，满意度和感知的帮助。主要终点将包括心理社会困扰和获益发现。此外，我们将评估和探索可能解释和阐明干预效果（中介变量）的合理干预机制和途径。将被测试的主要理论为基础的中介变量包括次要评价（应对自我效能）和应对努力。最后，根据本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，其最终目标是为癌症儿童的主要照顾者开发一种高效且可输出的电话咨询干预措施，该干预措施可能成为儿科肿瘤患者护理的一个组成部分。

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.