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心理社会需求，据估计，高达35%的癌症幸存者经历了临床上严重的痛苦。心理社会干预对改善这些患者的生活质量和降低情绪障碍水平可能是有效的。不幸的是，获得心理社会干预的障碍很常见，许多人无法获得这些服务。基于互联网的心理社会干预改善了护理的可及性，并提供了更多的方法优势，包括能够轻松收集自我报告数据、跟踪干预暴露情况以及评估特定干预组成部分的效果。PI进行的一项研究是仅有的三项基于互联网的心理社会干预对癌症适应影响的随机试验之一，这三项试验都仅限于专门为乳腺癌女性提供的过时的互联网干预。显然迫切需要对基于互联网的干预进行评估：a)具有将增加与干预组件交互的时间的现代特征(即，社交网络特征)；b)包括其他癌症(即，不仅仅是乳腺癌)；以及c)采用用于仔细跟踪干预的行为参与程度的系统。拟议研究的具体目标是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点和缺点，以及2)估计充分支持面对面和在线干预的较大对照试验所需的效果大小。为了实现这些目标，将使用基于登记的招募程序来识别最近被诊断为癌症的人，这些人目前正在经历与癌症有关的严重痛苦。有兴趣参与这项研究的个人将被随机分配到为期12周的互联网治疗组或12周的等待名单对照组。分配到治疗组的受试者将可以访问小组讨论板、为期12周的结构化应对技能培训课程、小组的专业促进、实时聊天板和其他小组成员建立的个人资料。受试者将被要求完成在线自我报告，在基线时和参加12周小组后再次自我报告痛苦、情绪障碍和生活质量。等待名单上的控制对象将能够在完成为期12周的评估后加入一个小组，并将被要求完成为期24周的评估，以衡量随着时间的推移的变化。据假设，与对照组相比，治疗组将在生活质量和情绪障碍方面表现出更大的改善，而且对干预材料的更多参与程度将与情绪和生活质量的更大改善相关。研究小组的长期目标是不断提高癌症幸存者心理社会干预的效果大小和可及性，并在一项面对面的试验中评估基于互联网和面对面干预的效果。与公共健康相关：只有少数几项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癌症幸存者提供心理治疗和加强沟通的网站是否可以改善癌症幸存者的痛苦，因为他们表示自己有很高的痛苦水平。如果成功，这项研究还将提供改善治疗所需的有价值的信息，并充分进行一项更大规模的试验，比较基于互联网的治疗和面对面治疗。

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of internet-based psychosocial intervention on adjustment to cancer, and all three of these trials were limited to now-outdated Internet interventions provided exclusively to women with breast cancer.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.