Evaluation of a social-networking intervention to reduce cancer-related distress

描述（由申请人提供）：癌症患者面临着一系列的社会心理需求，据估计，高达35%的癌症幸存者经历着临床显著水平的痛苦。社会心理干预可能对改善这些患者的生活质量和减少情绪障碍水平有效。不幸的是，获得社会心理干预的障碍很普遍，许多人无法获得这些服务。基于互联网的社会心理干预改善了护理的可及性，并提供了额外的方法优势，包括能够轻松收集自我报告数据，跟踪干预的暴露情况，并评估特定干预成分的效果。PI进行的一项研究是仅有的三个基于互联网的心理社会干预对癌症适应效果的随机试验之一，这三个试验都局限于现在已经过时的专门为乳腺癌女性提供的互联网干预。有一个明确而迫切的需求来评估基于互联网的干预：a)具有现代特征，将增加与干预组件（即社交网络功能）互动的时间，b)包括其他癌症（即不仅仅是乳腺癌），c)采用一个系统来仔细跟踪干预的行为参与水平。该研究的具体目的是1)评估在线社交网络干预的随机对照试验的可行性，并确定干预材料的主要优势和劣势；2)估计足够支持比较面对面和在线干预的更大规模对照试验所需的效应量。为了实现这些目标，将采用基于登记的招募程序来确定最近诊断出患有癌症的个体，这些个体目前正经历着与癌症相关的重大痛苦。有兴趣参与这项研究的个人将被随机分配到一个为期12周的基于互联网的治疗组或一个为期12周的等待名单对照组。被分配到治疗组的受试者将可以访问小组讨论板、结构化的为期12周的应对技能培训课程、小组的专业指导、实时聊天板和其他小组成员建立的个人资料。受试者将被要求在基线和12周后再次完成在线自我报告，测量痛苦、情绪障碍和生活质量。等候名单对照受试者在完成12周的评估后可以加入一个小组，并将被要求完成24周的评估，以衡量随时间的变化。据推测，与对照组相比，治疗组在生活质量和情绪障碍方面表现出更大的改善，并且更多地参与干预材料将与情绪和生活质量的更大改善有关。研究小组的长期目标是不断提高癌症幸存者的心理社会干预的效果大小和可及性，并在一对一的试验中评估基于互联网和面对面干预的效果。公共卫生相关性：只有少数研究评估了基于互联网的心理治疗对癌症患者痛苦的影响。这项拟议的研究将评估一个专门为提供心理治疗和加强癌症幸存者之间的沟通而开发的网站是否能改善那些表明自己有高度痛苦的癌症幸存者的痛苦。如果成功，该研究还将提供改善治疗所需的宝贵信息，并充分进行更大规模的试验，比较基于互联网的治疗和面对面的治疗。

DESCRIPTION (provided by applicant): Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. A study conducted by the PI is one of only three randomized trials of the effects of internet-based psychosocial intervention on adjustment to cancer, and all three of these trials were limited to now-outdated Internet interventions provided exclusively to women with breast cancer. There is a clear and pressing need to evaluate an internet-based intervention that: a) has modern features that will increase the amount of time spent interacting with intervention components (i.e., social-networking features), b) is inclusive of other cancers (i.e., not just breast cancer), and c) employs a system for carefully tracking levels of behavioral engagement with the intervention. The specific aims of the proposed study are 1) to evaluate the feasibility of a randomized, controlled trial of an online social-networking intervention and to identify key strengths and weaknesses of the intervention materials and 2) to estimate effect sizes necessary for adequately powering a larger controlled trial comparing face-to-face and online interventions. To accomplish these aims, a registry-based recruitment procedure will be used to identify recently diagnosed individuals with cancer who are currently experiencing significant cancer-related distress. Individuals interested in participating in the study will be randomized to receive access to a 12-week internet-based treatment group or to a 12-week waiting list control group. Subjects assigned to the treatment group will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group. Wait-list control subjects will be able to join a group after they complete the 12-week assessment and will be asked to complete a 24-week assessment in order to measure change over time. It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life. Long-term goals of the research team are to continually improve effect sizes and accessibility of psychosocial interventions for cancer survivors and to evaluate the effects of internet-based and face-to-face interventions in a head-to-head trial. PUBLIC HEALTH RELEVANCE: Only a handful of studies have evaluated the effects of internet-based psychological treatments for distress in those living with cancer. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.