Reducing distress and tobacco smoking in cancer survivors: a TDCS telehealth study

减少癌症幸存者的痛苦和吸烟：TDCS 远程医疗研究

• 批准号: 10390202
• 负责人: Merideth A. Addicott
• 金额: $ 25.01万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390202
• 关键词: Acceleration; Adjuvant; Affect; Anodes; Anxiety; Base of the Brain; Behavior; Behavior Therapy; Behavioral; Bilateral; Brain; COVID-19; COVID-19 pandemic; Cancer Patient; Cancer Survivor; Cathodes; Cessation of life; Clinic Visits; Clinical; Clinical Treatment; Clinical Trials; Consult; Counseling; Coupled; Data; Devices; Disease; Distress; Double-Blind Method; Drug usage; Emotional; Emotions; Exhalation; Future; Goals; Health Status; Home; Home environment; Immunocompromised Host; Individual; Intervention; Irritable Mood; Lead; Left; Letters; Linear Regressions; Link; Malignant Neoplasms; Malignant neoplasm of lung; Measures; Mental Depression; Modeling; Monitor; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Prefrontal Cortex; Protocols documentation; Provider; Psychotherapy; Publications; Questionnaires; Randomized; Recording of previous events; Research; Risk Factors; Safety; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Supervision; Survivors; Target Populations; Techniques; Therapeutic; Time; TimeLine; Tobacco; Tobacco smoking behavior; Transcranial magnetic stimulation; Treatment Protocols; Visit; addiction; base; cancer diagnosis; cigarette smoking; dysphoria; eligible participant; evidence base; executive function; experience; follow-up; innovation; interest; intervention effect; member; mindfulness meditation; modifiable risk; multimodality; negative affect; negative emotional state; neuroregulation; noninvasive brain stimulation; novel; novel therapeutics; psychological distress; recruit; remote delivery; remote intervention; retention rate; smoking cessation; telehealth; tool; treatment duration; video visit; wireless

Project Summary/Abstract Cigarette smoking is the most prevalent cause of lung cancer, and also the strongest modifiable risk factor for cancer deaths among survivors. Unfortunately, the psychological distress associated with a cancer diagnosis makes smoking cessation particularly challenging for these patients. Distress itself is one of the core features of Koob & Volkow’s 3-stage model of addiction. Each of these stages is regulated by complementary brain circuits – which represent putative treatment targets. The long term goal of our research team is to develop an evidence- based brain stimulation treatment protocol for smoking cessation which is accessible, scalable, and an adjuvant to pharmacotherapy or psychotherapy among cancer survivors. Before embarking on a large multisite and multimodal clinical trial, however, it is critical to evaluate feasibility of delivering RS-tDCS to our target population (Aim 1) as well as estimated effect sizes on distress (Aim 2A) and smoking (Aim 2B). (Scientific Gap). Our team has developed and extensively validated a protocol for remotely supervised neuromodulation intervention which is delivered to participants at home and monitored by clinician during a telehealth visit. This remotely supervised technique utilizes transcranial direct current stimulation (RS-tDCS) and can be delivered safely via daily telehealth visits for extended treatment periods to provide cumulative benefit. Building on an established body of work, we seek to decrease distress among individuals with a prior cancer diagnosis and TUD via DLPFC tDCS. The goal of this proposal is to evaluate this technique as a feasible (Aim 1) tool to decrease distress and cigarette smoking (Aim 2) among this population. We propose a double-blind sham- controlled trial of a completely at-home intervention - RS-tDCS (DLFPC, 2.0 mA) paired with guided mindfulness meditation as a tool to decrease distress and smoking behavior among individuals with TUD. Eligible participants with a prior cancer diagnosis and TUD (n=46) will be randomized to active vs. sham tDCS for 20 daily (M-F) x 20 min sessions over one month, followed by 3 monthly follow up video visits. We hypothesize that active vs. sham tDCS will lead to greater reductions in distress and decrease smoking behaviors (Aim 2) by treatment end (primary) and through the 3 month follow up (secondary). The need for scalable, remote therapeutics which can be coupled with telehealth counseling techniques is more important than ever given the worldwide burden of COVID-19, including stay-at-home orders and an unprecedented acceleration in smoking and tobacco purchases. RS-tDCS as a tool to reduce distress and smoking behavior in people’s own homes represents a next-generation therapeutic approach– an important step forward for individuals struggling with a prior cancer diagnosis and current TUD, and is especially timely amidst the COVID-19 pandemic.

项目总结/摘要 吸烟是肺癌最常见的原因，也是最强的可改变的风险因素， 幸存者中的癌症死亡人数。不幸的是，癌症诊断带来的心理困扰 这使得戒烟对这些患者来说特别具有挑战性。痛苦本身就是 Koob & Koobow的成瘾三阶段模型。每一个阶段都是由互补的大脑回路调节的 - 其代表假定的治疗靶点。我们研究团队的长期目标是开发证据- 基于脑刺激的戒烟治疗方案，易于使用、可扩展且是一种辅助剂 癌症幸存者的药物治疗或心理治疗。在开始一个大型的多站点和 然而，多模式临床试验，关键是评估将RS-tDCS输送到我们的目标人群的可行性 (Aim 1）以及对痛苦（目标2A）和吸烟（目标2B）的估计效应量。（科学鸿沟）。 我们的团队已经开发并广泛验证了远程监督神经调节的协议 在远程保健访问期间，向在家的参与者提供并由临床医生监测的干预。这 远程监督技术利用经颅直流电刺激（RS-tDCS）， 安全地通过每日远程保健访问延长治疗期，以提供累积效益。建立在 建立的工作机构，我们寻求减少个人与先前的癌症诊断， TUD通过DLPFC tDCS。本提案的目的是评估该技术作为一种可行的（目标1）工具， 减少这一人群的痛苦和吸烟（目标2）。我们提出一个双盲的假手术- 完全在家干预的对照试验- RS-tDCS（DLFPC，2.0 mA）与引导正念配对 冥想作为减少TUD患者痛苦和吸烟行为的工具。合资格参与者 既往诊断为癌症且TUD的患者（n=46）将随机分为活性tDCS组与假tDCS组，每日20次（M-F）x 在一个月内进行20分钟的会话，然后每月进行3次随访视频访视。我们假设，积极与。 到治疗结束时，假tDCS将导致更大程度的痛苦减轻和吸烟行为减少（目标2） （主要）和3个月随访（次要）。 对可扩展的远程治疗的需求，可以与远程健康咨询技术相结合， 考虑到COVID-19的全球负担，包括居家订单和 吸烟和烟草购买空前加速。RS-tDCS作为一种工具，以减少痛苦和 在人们自己家里吸烟的行为代表了下一代的治疗方法-一个重要的步骤 对于那些与先前的癌症诊断和当前的TUD作斗争的人来说，这是非常及时的， COVID-19大流行。