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

治疗农村癌症幸存者痛苦的阶梯式护理远程医疗方法

• 批准号: 9100255
• 负责人: GRETCHEN A BRENES
• 金额: $ 20.23万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-14 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9100255
• 关键词: Address; Adherence; Adult; Aftercare; Age; American Society of Clinical Oncology; Anxiety; Behavioral; Cancer Burden; Cancer Survivor; Cancer Survivorship; Caring; Cognitive; Cognitive Therapy; Colorectal Cancer; Communities; Community Clinical Oncology Program; Data; Distress; Elderly; Fatigue; Female Breast Carcinoma; Fright; Funding; Guidelines; Health Care Costs; Health Personnel; Individual; Intervention; Life; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Mental Depression; Mental Health; Methods; Non-Hodgkin' s Lymphoma; Outcome; Pain; Participant; Pilot Projects; Population; Protocols documentation; Psychiatric therapeutic procedure; Psychosocial Assessment and Care; Psychotherapy; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Recruitment Activity; Recurrence; Reporting; Research; Research Infrastructure; Resources; Rural; Rural Community; Rural Population; Severities; Site; Sleep; Sleep disturbances; Survivors; Symptoms; Telephone; Testing; United States National Institutes of Health; Work; adverse outcome; anxiety symptoms; arm; base; cancer health disparity; cancer type; clinically significant; cost; cost effective; depressive symptoms; design; emotional distress; evidence base; experience; forest; health care service utilization; health disparity; improved; individualized medicine; innovation; intervention effect; personalized approach; physical conditioning; post intervention; programs; psychologic; psychosocial; public health relevance; rural area; screening; secondary outcome; survivorship; telehealth; theories; treatment as usual

 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.

 描述（由申请人提供）：心理困扰，包括焦虑和抑郁症状，在治疗后的癌症幸存者中很常见，并与多种不良后果相关，包括睡眠障碍、疲劳和生活质量 (QOL) 下降。迫切需要为经历严重痛苦的治疗后癌症幸存者提供干预措施，特别是在心理社会护理稀缺的农村地区。最近的国家指南建议对所有患有癌症的成年人进行筛查，并采用分级护理方法治疗那些患有中度至重度症状的人。这项试点研究的目的是使用认知行为治疗 (CBT) 方案在农村社区肿瘤学环境中实施阶梯式护理方法，其中包括自我指导和远程医疗方法。具体目标是：(1) 确定对 90 名具有中度至重度痛苦（焦虑和/或抑郁症状）的农村治疗后癌症幸存者进行分级护理心理健康干预（根据症状水平定制）与强化常规护理 (EUC) 的随机对照试验的可行性（应计、保留、依从性）； (2) 获得减少情绪困扰和改善次要结局（睡眠障碍、疲劳、担心复发、生活质量）的初步疗效数据； (3) 确定干预成本。我们将招募 90 名成年（年龄≥18 岁）农村癌症幸存者，她们在女性乳腺癌、结直肠癌、前列腺癌或妇科癌症或非霍奇金淋巴瘤治疗后 6-24 个月，并且报告有临床上显着的焦虑或抑郁症状。参与者将根据症状严重程度进行分层，并随机接受分级护理或 EUC。对于有中度症状、低强度的参与者，阶梯式护理将包括自助 CBT 工作簿和每两周一次的电话报到，以评估症状严重程度的变化/是否立即需要精神治疗，并提供最低限度的支持。对于有中度至重度症状的参与者，高强度分级护理将包括 CBT 工作簿和通过电话提供的心理治疗。随机分配到 EUC 的参与者将获得生存资源和当地心理健康提供者的转诊信息。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，并利用现有的 NCI 资助的研究基地基础设施。这项工作的创新之处在于其重点是通过阶梯式护理干预来解决农村癌症幸存者的心理健康差异。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，因为它将通过电话进行手动操作，并由模块组成，以便为患有不同癌症类型的个体提供定制治疗。