A Stepped-Care Telehealth Approach to Treat Distress in Rural Cancer Survivors

 描述(由申请人提供)：心理社会困扰，包括焦虑和抑郁症状，在治疗后的癌症幸存者中很常见，并与多种不良后果有关，包括睡眠障碍、疲劳和生活质量(QOL)下降。迫切需要为遭受严重痛苦的癌症治疗后幸存者提供可获得的干预，特别是在缺乏心理社会护理的农村地区。最近的国家指南建议对所有患有癌症的成年人进行痛苦筛查，并使用分步护理方法治疗那些有中度到重度症状的人。这项试点研究的目的是在农村社区肿瘤学环境中使用认知-行为疗法(CBT)方案实施分级护理方法，该方案包括自我指导和远程保健方法。具体目的是：(1)确定一项随机对照试验的可行性，即分级护理心理健康干预(根据症状水平定制)与加强日常护理(EUC)的对照试验；(2)对90名有中度至重度痛苦(焦虑和/或抑郁症状)的农村癌症患者进行循序渐进护理心理健康干预(EUC)；(2)获得缓解情绪困扰和改善二次结局(睡眠障碍、疲劳、害怕复发、生活质量)的初步疗效数据；(3)确定干预成本。我们将招募90名成人(年龄18岁)，农村癌症幸存者，他们在女性乳腺癌、结直肠癌、前列腺癌、妇科癌症或非霍奇金淋巴瘤治疗后6-24个月，并报告临床上有明显的焦虑或抑郁症状。参与者将根据症状严重程度进行分层，并随机进入分级护理或EUC。对于中度症状的参与者，低强度、分级护理将包括一本自我指导的CBT工作簿和两周一次的登记电话，以评估症状严重程度的变化/精神治疗的迫切需要，并提供最低限度的支持。对于有中度到重度症状的参与者，高强度的分级护理将包括一本CBT练习册和通过电话提供的心理治疗。被随机分配到EUC的参与者将获得生存资源和当地精神卫生提供者的转介信息。这些措施将在干预前、干预中和干预后通过电话和邮件实施。拟议的研究有效地建立在先前和当前研究的基础上，并利用NCI资助的现有研究基地基础设施。这项工作的创新之处在于，它的重点是通过分步护理干预解决农村癌症幸存者的心理健康差距。这项研究完成后，我们将在社区癌症环境中实施一项全面的研究。由此产生的干预措施将具有广泛传播的巨大潜力，因为它将是手动的，通过电话提供，并包括允许为不同癌症类型的个人进行定制治疗的模块。

 DESCRIPTION (provided by applicant): Psychosocial distress, including anxiety and depressive symptoms, is common in post-treatment cancer survivors and associated with multiple adverse outcomes, including sleep disturbance, fatigue and decreased quality of life (QOL). Interventions that are accessible to post-treatment cancer survivors experiencing significant distress are sorely needed, especially in rural areas where psychosocial care is scarce. Recent national guidelines recommend screening all adults with cancer for distress and treating those with moderate to severe symptoms using a stepped-care approach. The purpose of this pilot study is to implement a stepped- care approach in rural community oncology settings using a cognitive-behavioral therapy (CBT) protocol that includes both self-directed and telehealth approaches. Specific aims are to: (1) determine feasibility (accrual, retention, adherence) of a randomized controlled trial of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care (EUC) in 90 rural, post-treatment cancer survivors with moderate to severe levels of distress (anxiety and/or depressive symptoms); (2) obtain preliminary efficacy data for reducing emotional distress and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, QOL); and (3) determine intervention costs. We will recruit 90 adult (age ≥18), rural cancer survivors who are 6-24 months post-treatment for female breast, colorectal, prostate, or gynecologic cancer or non-Hodgkin's lymphoma and who report clinically significant anxiety or depressive symptoms. Participants will be stratified by symptom severity and randomized to stepped-care or EUC. For participants with moderate symptoms, low- intensity, stepped care will consist of a self-guided CBT workbook and biweekly check-in calls to assess changes in symptom severity/immediate need for psychiatric treatment and to provide minimal support. For participants with moderate to severe symptoms, high-intensity stepped care will consist of a CBT workbook and psychotherapy delivered by telephone. Participants randomized to EUC will receive survivorship resources and referral information for local mental health providers. Measures will be administered by telephone and mail at pre-, mid- and post-intervention. The proposed study efficiently builds on prior and current research and leverages the existing NCI-funded Research Base infrastructure. The innovation of this work is its focus on addressing a mental health disparity among rural cancer survivors through a stepped-care intervention. After this study is completed, we will implement a fully-powered study in the community cancer setting. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.