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: 10680370
• 负责人: Merideth A. Addicott
• 金额: $ 19.77万
• 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/10680370
• 关键词: Acceleration; Adjuvant; Affect; Anodes; Anxiety; Back; 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; Remote session; Research; Risk Factors; Safety; Site; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Survivors; Target Populations; Techniques; Therapeutic; Tobacco; Tobacco smoking behavior; Transcranial magnetic stimulation; Treatment Protocols; Visit; addiction; brain based; 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; stay-at-home order; telehealth; timeline; tool; transcranial direct current stimulation; treatment duration; video visit; wireless transmission

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/文摘