Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
批准号:
10285671
负责人:
Sriram Yennu
金额:
$22.72万
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-07-08 至 2023-06-30
关键词:
AddressAlcohol consumptionAnxietyArea Under CurveBehaviorBehavioral MechanismsBrainBrain regionCancer CenterCancer PatientClinicalCustomDataDiseaseDoseElectroencephalogramEthicsEtiologyEyeFamilyFrequenciesGoalsGoldHead and Neck CancerHealthHospitalsHuman PapillomavirusIncidenceInterventionInvestigationLightLiteratureMalignant NeoplasmsMeasuresMediatingMental DepressionMethodologyModalityMoodsOpioidOutcomePainPain Management MethodPain intensityPain managementParticipantPatientsPatternPhasePhysiological ProcessesPilot ProjectsQuality of lifeQuestionnairesRadiation therapyRandomizedRandomized Controlled TrialsResearch DesignRiskRisk BehaviorsRisk FactorsSecondary toSeveritiesSmoking HistoryStandardizationSymptomsTechniquesTestingTherapeuticTimeWorkaddictionadherence rateadverse outcomebasebehavior changecancer painclinically relevantcommon symptomdisabling symptomeffective therapyexperiencehead and neck cancer patienthigh riskinsightintervention effectmorphine equivalentneurofeedbackneuroregulationnovelopioid epidemicopioid misuseopioid sparingopioid therapyopioid usepain reductionpain reliefpatient orientedprescription opioidpsychological distresspsychosocialstandard carestandard of caretreatment arm
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PROJECT SUMMARY
BACKGROUND: For patients with head and neck cancer receiving radiation therapy (HNC), the frequency of
substantial pain may be as high as 60 to 90% due to both the disease and its treatment. In the face of the
opioid crisis, there has been a universal push for opioid-sparing treatments in patients with pain; however, this
is not a viable option for most HNC patients experiencing pain, as there remains a lack of alternative pain
control modalities. Our preliminary data suggest that in HNC patients, there is a higher risk of non-medical
opioid use (NMOU) and a higher frequency of positive CAGE (Cut Down, Annoyed, Guilty, and Eye opener)
scores. The high NMOU risk exposes patients and their families to harm, but patients still need effective pain
relief. There is, therefore, a critical need to find new and effective methods for management of pain in patients
with HNC who have a high risk of NMOU. This proposal will focus on two promising interventions targeting
different underlying mechanisms of NMOU. CHAT (Compassionate High Alert Team) is an intensive,
manualized, interdisciplinary, and patient-centered approach to manage patients with a high risk of NMOU.
Neurofeedback (NFB) has shown promise in controlling pain and concomitant psychosocial aspects of pain.
However, to date there are no studies of NFB for NMOU risk behaviors in cancer patients receiving treatment.
OBJECTIVES: The long-term objective of this work is to devise effective strategies to manage cancer patients
with NMOU behaviors, but who must be prescribed an opioid to treat their pain.
SPECIFIC AIMS: 1. To test the hypothesis that this study will be feasible, as defined by adequate rates of
adherence in the CHAT and NFB groups. 2. To examine the frequency of NMOU behaviors at the end of 3
months after CHAT, NFB, and SOC. 3. We will examine the pain severity [area under the curve (AUC)] and
daily opioid use [AUC of the cumulative morphine equivalent daily dose (MEDD)] for each of the treatment
arms (CHAT, NFB, or SOC) in HNC patients at the end of 3 months. 4. To examine the cortical and subcortical
regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which
changes in EEG patterns mediate the effects of the intervention.
RESEARCH DESIGN: This will be a Phase 2 randomized controlled trial. Patients with HNC will be screened
for evidence of NMOU risk and offered the opportunity to participate in the study if they screen positive. Patients
will be randomized to either CHAT, NFB, or SOC. We will assess the feasibility, change in frequency of NMOU
behaviors, change in pain severity [area under the curve (AUC)] and daily opioid use AUC of the cumulative
morphine equivalent daily dose (MEDD) at the end of 3 months after CHAT, NFB, and SOC. Finally, the
exploratory aim in this proposal will generate exciting new insight into the problem of pain, NMOU behavior, and
mechanisms of CHAT and NFB. This study could identify two novel patient approaches to NMOU management,
CHAT and NFB, with the potential to positively impact the lives of cancer patients across the U.S. and worldwide.
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Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
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批准号:10447805
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项目类别:
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资助金额:$18.56万
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财政年份:2021
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负责人:Sriram Yennu
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资助金额:$20.61万
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财政年份:2018
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负责人:Sriram Yennu
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A Combination Therapy to Treat Cancer-Related Fatigue
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批准号:10531872
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项目类别:
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资助金额:$49.8万
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财政年份:2018
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负责人:Sriram Yennu
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依托单位:
A Combination Therapy to Treat Cancer-Related Fatigue
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批准号:10308673
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项目类别:
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资助金额:$47.58万
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财政年份:2018
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负责人:Sriram Yennu
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依托单位:
A Combination Therapy to Treat Cancer-Related Fatigue
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批准号:10063816
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项目类别:
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资助金额:$48.39万
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财政年份:2018
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负责人:Sriram Yennu
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依托单位:
海外基金