grant

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

Organization WAKE FOREST UNIVERSITY HEALTH SCIENCESLocation WINSTON-SALEM, UNITED STATESPosted 15 Aug 2022Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY2023AccelerationActive Follow-upAdjuvantAffectAnodesAnxietyBackBehaviorBehavior Conditioning TherapyBehavior ModificationBehavior TherapyBehavior TreatmentBehavioralBehavioral Conditioning TherapyBehavioral ModificationBehavioral TherapyBehavioral TreatmentBilateralBrainBrain Nervous SystemCOVID crisisCOVID epidemicCOVID pandemicCOVID-19COVID-19 crisisCOVID-19 epidemicCOVID-19 global health crisisCOVID-19 global pandemicCOVID-19 health crisisCOVID-19 pandemicCOVID-19 public health crisisCOVID19COVID19 crisisCOVID19 epidemicCOVID19 global health crisisCOVID19 global pandemicCOVID19 health crisisCOVID19 pandemicCOVID19 public health crisisCV-19CV19Cancer PatientCancer SurvivorCancersCathodesCessation of lifeClinic VisitsClinicalClinical TreatmentClinical TrialsConditioning TherapyConsultCounselingCoupledDataDeathDevicesDiseaseDisorderDistressDorsumDouble-Blind MethodDouble-Blind StudyDouble-BlindedDouble-Masked MethodDouble-Masked StudyDrug TherapyDrug usageDrugsEmotionalEmotionsEncephalonExhalationExhalingFutureGoalsHealth StatusHistoryHomeHome environmentImmunocompromisedImmunocompromised HostImmunocompromised PatientImmunosuppressed HostIndividualInterventionIntervention StrategiesIrritable MoodLeadLeftLettersLevel of HealthLinear RegressionsLinkMalignant NeoplasmsMalignant TumorMalignant Tumor of the LungMalignant neoplasm of lungMeasuresMedicationMental DepressionModelingMonitorParticipantPatient Self-ReportPatientsPb elementPersonsPharmaceutic PreparationsPharmaceutical PreparationsPharmacotherapyPopulationPrefrontal CortexProtocolProtocols documentationProviderPsychotherapyPublicationsPulmonary CancerPulmonary malignant NeoplasmQuestionnairesRandomizedRecording of previous eventsRemote sessionResearchRespiratory ExpirationRisk FactorsSARS-CoV-2 epidemicSARS-CoV-2 global health crisisSARS-CoV-2 global pandemicSARS-CoV-2 pandemicSARS-CoV2 epidemicSARS-CoV2 pandemicSARS-coronavirus-2 epidemicSARS-coronavirus-2 pandemicSafetyScientific PublicationSelf-ReportSevere Acute Respiratory Syndrome CoV 2 epidemicSevere Acute Respiratory Syndrome CoV 2 pandemicSevere acute respiratory syndrome coronavirus 2 epidemicSevere acute respiratory syndrome coronavirus 2 pandemicSiteSmokerSmokingSmoking BehaviorSmoking Cessation InterventionSurvivorsTarget PopulationsTechniquesTherapeuticTobaccoTobacco smokingTobacco smoking behaviorTranscranial magnetic stimulationTreatment PeriodTreatment ProtocolsTreatment RegimenTreatment ScheduleVisitactive followupaddictionaddictive disorderbehavior interventionbehavioral interventionbrain basedcancer diagnosiscease smokingcigarette smokingcigarette useconsultscorona virus disease 2019corona virus disease 2019 epidemiccorona virus disease 2019 pandemiccoronavirus disease 2019coronavirus disease 2019 crisiscoronavirus disease 2019 epidemiccoronavirus disease 2019 global health crisiscoronavirus disease 2019 global pandemiccoronavirus disease 2019 health crisiscoronavirus disease 2019 pandemiccoronavirus disease 2019 public health crisiscoronavirus disease crisiscoronavirus disease epidemiccoronavirus disease pandemiccoronavirus disease-19coronavirus disease-19 global pandemiccoronavirus disease-19 pandemiccoronavirus infectious disease-19delivered remotelydepressiondrug treatmentdrug usedrug/agentdysphoriaeligible participantevidence baseexecutive controlexecutive functionexperiencefollow upfollow-upfollowed upfollowupheavy metal Pbheavy metal leadhistorieshomesimmunosuppressed patientinnovateinnovationinnovativeinterestintervention effectinterventional strategylung cancermalignancymalleable riskmembermindfulness meditationmodifiable riskmulti-modalitymultimodalitynegative affectnegative affectivitynegative emotional stateneoplasm/cancerneural controlneural regulationneuromodulationneuromodulatoryneuroregulationnew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnon-invasive brain stimulationnoninvasive brain stimulationnovelnovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapypsychological distressquit smokingrandomisationrandomizationrandomly assignedrecruitremote deliveryremote interventionretention rateretention strategysevere acute respiratory syndrome coronavirus 2 global health crisissevere acute respiratory syndrome coronavirus 2 global pandemicsmoking cessationsmoking cessation treatmentstay-at-home mandatestay-at-home orderstay-at-home ordinancestay-at-home policystop smokingtelehealthtimelinetooltranscranial direct current stimulationtreatment daystreatment durationtrial regimentrial treatmentvideo visitwireless transmission
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Full Description

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.

Grant Number: 5R21DA055426-02
NIH Institute/Center: NIH

Principal Investigator: Merideth Addicott

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