grant

Development and piloting of an intervention to reduce the impact of opioid stigma in cancer pain

Organization UNIVERSITY OF ALABAMA AT BIRMINGHAMLocation BIRMINGHAM, UNITED STATESPosted 1 Sept 2025Deadline 31 Aug 2027
NIHUS FederalResearch GrantFY2025AddressAdvanced CancerAdvanced Malignant NeoplasmAdverse ExperienceAdverse eventAreaAssertivenessAwardBehaviorBehavior Conditioning TherapyBehavior ModificationBehavior TherapyBehavior TreatmentBehavioralBehavioral Conditioning TherapyBehavioral ModificationBehavioral TherapyBehavioral TreatmentCancer Pain ManagementCancer TreatmentCancersCare GiversCaregiversCatchment AreaCessation of lifeCharacteristicsClient satisfactionClinical Practice GuidelineCommunicationCommunication challengeCommunication difficultyCommunitiesComprehensive Cancer CenterConditioning TherapyConduct Clinical TrialsCoping SkillsDataDeathDedicationsDevelopmentElementsEnrollmentFearFeedbackFoundationsFrightFutureHealthHealth behaviorImpairmentInstitutionInterventionIntervention TrialInterventional trialInvestigatorsLabelLinkLiteratureMalignant Neoplasm TherapyMalignant Neoplasm TreatmentMalignant NeoplasmsMalignant TumorMentorsMentorshipMethodologyMissionOncologyOncology CancerOpiatesOpioidOpioid AnalgesicsOutcomeOutcome AssessmentOverdosePainPain ControlPain TherapyPain managementPain qualityPainfulParticipantPatient RecruitmentsPatient SatisfactionPatientsPersonal SatisfactionPersonsPreparationPrincipal InvestigatorProcessPublishingQOLQualitative ResearchQuality of lifeRandomization trialRandomizedRandomized, Controlled TrialsRecommendationReportingResearchResearch MethodologyResearch MethodsResearch PersonnelResearch ResourcesResearchersResourcesSocial isolationStereotypingStress and CopingSurvey InstrumentSurveysSymptomsTestingTrainingUnited Statesacceptability and feasibilityaddictionaddictive disorderadherence rateadverse consequenceadverse outcomeanti-cancer therapybehavior interventionbehavioral interventioncancer paincancer therapycancer-directed therapycare as usualcareercareer developmentclinical practice and guidelinescommunity interventioncommunity level interventioncommunity-based interventionconcept mappingconcept mapscoping strategycoping with stressdesigndesigningdevelop therapydevelopmentalefficacy testingefficacy trialemotional distressenrollexperiencefeeling distressfeeling upsethealth related behaviorhealth related quality of lifeimprovedinnovateinnovationinnovativeinternalized stigmaintervention developmentlicit opioidmalignancymultidisciplinaryneoplasm/cancernovelopiate analgesiaopiate analgesicopiate consumptionopiate crisisopiate drug useopiate intakeopiate medicationopiate pain medicationopiate pain relieveropiate useopioid analgesiaopioid anestheticopioid consumptionopioid crisisopioid drug useopioid epidemicopioid guidelineopioid intakeopioid lawopioid legislationopioid medicationopioid pain medicationopioid pain relieveropioid painkilleropioid policyopioid usepain interventionpain treatmentpalliativeparticipant engagementparticipant recruitmentpatient engagementpatient-clinician communicationpatient-doctor communicationpatient-provider communicationpilot testpilot trialpost interventionpreparationsprescribed opiateprescribed opioidprescription opiateprescription opioidprimary outcomerandomisationrandomizationrandomized control trialrandomized trialrandomly assignedresearch and methodsself-stigmaskillssocialsocial cognitive theorysocial learning theorysocial stigmasocio-demographicssociodemographicsstigmastress-related copingtheoriestherapy developmenttooltreatment as usualtreatment developmentusual carewell-beingwellbeing
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Full Description

Moderate-to-severe cancer pain is common in patients with advanced cancer and is often effectively treated with prescription opioids. Effective pain management is crucial for optimal quality of life and health outcomes in these patients. However, the emergence of the opioid crisis in the United States has sparked widespread fears about the use of opioid pain medications, given the potential for negative outcomes such as addiction and overdose. Despite being exempted from restrictive opioid policies, patients with cancer experience adverse consequences of efforts to address the opioid crisis, including stigma associated with prescription opioid use (“opioid stigma”).

Based on our recently published Opioid Stigma Framework, we anticipate that opioid stigma results in several proximal (e.g., impaired patient-provider communication, suboptimal health behaviors, emotional distress, maladaptive coping skills) and long-term health consequences (e.g., less effective pain management, reduced health-related quality of life). Emerging evidence indicates that opioid stigma is common, pervasive, and has the potential to seriously impact patient well-being. However, there are no known interventions to mitigate opioid stigma in patients with advanced cancer. Thus, the proposed project will develop and test a novel behavioral intervention for opioid stigma in an effort to fill this unmet need.

Together with her mentors, Principal Investigator Dr. Bulls will explore opioid stigma experiences and treatment priorities reported by 75 patients with advanced, painful cancer using rigorous concept mapping methodology (Aim 1). Next, Dr. Bulls will design a theory-based intervention to reduce negative proximal impacts of opioid stigma in patients with advanced cancer, soliciting feedback from patients and community-engaged institutional resources prior to piloting (Aim 2).

Finally, Dr. Bulls will conduct a pilot trial of the intervention with 45 patients with advanced cancer pain to evaluate feasibility and acceptability in preparation for a full-scale randomized controlled trial (Aim 3). This project will facilitate training crucial to Dr. Bulls’ career development: advanced skills in participatory and stakeholder-engaged research methods, in-depth training in behavioral intervention development, and expertise in conducting clinical trials.

Dr. Bulls has convened a dedicated, multidisciplinary mentorship team with expertise in essential content and methodological areas including palliative oncology, opioid pain management, health-related stigma, concept mapping, behavioral intervention development and testing, and recruitment of patients living with advanced cancer, among others. This proposal represents a comprehensive training, mentoring, and research plan to support Dr. Bulls’ transition into a successful independent investigator.

At the end of the award period, Dr. Bulls will contribute substantially to the field as a leader in behavioral approaches to improve opioid stigma in patients with advanced cancer.

Grant Number: 7K08CA263317-04
NIH Institute/Center: NIH

Principal Investigator: Hailey Bulls

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