Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365633
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2022-04-12
Brief Title:
Empowering LGBTQ Tobacco Cessation Pilot
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Empowering Sexual andor Gender Minority Tobacco Cessation A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sexual andor gender minority SGM people have disproportionately high rates of tobacco use - the number one cause of preventable death Reasons for this include using tobacco to cope with social minority stressors pro-tobacco use norms in SGM social spaces and networks and targeted tobacco industry marketing Empowerment Theory explains how positive behavior change like quitting smoking can be promoted through skills development with greater participation in the public affairs of ones community An empowerment approach may enhance tobacco cessation treatment for SGM people and other stigmatized groups because it links individual well-being with the larger social and political context This pilot study will assess the acceptability feasibility and preliminary impact of empowerment-enhanced tobacco smoking cessation assistance for SGM adults We will enroll N20 SGM adults in Oklahoma who smoke and are willing to quit Participants will receive standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program TTRP Concurrently they will also engage in empowerment activities meaning SGM organizing and community-building activities like conducting follow-up phone calls to gender marker and name correction clinic participants This will be guided by an Oklahoman SGM-serving community partner Participants will complete 8 surveys during the intervention period and 12 weeks post-quit-date a 60-minute in-depth exit interview and biochemically-verified smoking status before the intervention and 12 weeks post-quit-date This pilot study will establish collaborative relationships between the PIs team and local SGM-serving organizations and will produce preliminary findings to support future R01-level funding to conduct a fully-powered randomized control trial of a multi-level empowerment-enhanced SGM tobacco cessation intervention
Detailed Description:
Aim 1 Assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for sexual andor gender minority SGM adults Use baseline and exit surveys and in-depth interviews to assess retention empowerment activity participation eg number duration intensity roles and participants perceptions of the intervention
Aim 2 Compare individual empowerment and cessation predictors pre- and post-intervention Hypothesis Post intervention participants will have i increased adaptive coping strategies social support and smoking abstinence self-efficacy and ii decreased internalized SGM stigma
Aim 3 Assess tobacco cessation outcomes post-intervention Hypothesis The proportion of participants with biochemically-verified smoking abstinence at 12 weeks post-quit-date will be equal to or greater than the general Stephenson Cancer Center Tobacco Treatment research Program TTRP intervention ie 18 biochemically-verified abstinence at 12 weeks1 medication and counseling adherence will be moderateoptimal for 50 of treatment weeks
Study overview This study will assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for SGM adults A single-arm pilot design will be used given funding time and sampling pool limits Participants N20 will receive standard TTRP tobacco cessation assistance and concurrently participate in SGM empowerment activities Outcomes will be assessed quantitatively and qualitatively Primary outcome variables will be retention perceptions of the intervention adaptive coping strategies biochemically-verified smoking abstinence at 12 weeks post-quit-date and treatment adherence
Recruitment Participants will be enrolled over a 4-month period and recruit through the TTRP which serves an average of 30 SGM individuals per year without SGM-targeted recruitment This will be supplement by recruiting via local SGM-serving organizations SGM targeted social media ads eg Facebook and snowball recruitment
Intervention Participants will receive standard TTRP tobacco cessation assistance either remotely or in-person 6 weekly counseling sessions and 12 weeks of combination NRT nicotine patches nicotine gum or lozenges During the 6 weeks of counseling participants will also engage in at least 4 empowerment activities ie SGM social change mobilization and community-building activities48 for a total of at least 8 hours Activities will be tailored to each participants comfort level and provide COVID-19 risk-reduction options eg remote or masked outdoor activities Examples are i running tobacco-free Pride events that occur in Jun and Oct in OK ii organizing a virtual SGM town hall to inform the OK State Plan on Aging iii SGM-relevant legislative phone banking eg regarding transgender student participation in school athletics and iv follow-up surveying of Freedom OKs name and gender marker change clinic72 participants
Participants will complete the following assessments i 8 surveys baseline exit quit-day 1-4 and 12 weeks post-quit-date ii biochemically-verified smoking status at baseline and 12 weeks post-quit-date via expired carbon monoxide monitors and iii a 60-minute in-depth interview over Zoom video chat within weeks 6-8 post-quit-date Participants will be incentivized a total of 200 for the baseline survey 25 6 subsequent surveys 70 2 expired carbon monoxide tests 20 exit survey 25 and 60-minute interview 60 Freedom Oklahoma staff will participate in interviews and reflect on the intervention and Freedom OKs role in it Freedom Oklahoma will adopt a tobacco-free policy and provide feedback on the cultural competence of TTRP materials
Partnerships TTRP will provide the standard tobacco cessation assistance Freedom Oklahoma will design the empowerment activities Freedom Oklahoma is a community-based organization in Oklahoma City that has worked to secure lived equality and legal protection for SGM Oklahomans for over 15 years PI McQuoid and Freedom OK have held more than 4 project planning meetings over the past year
Measurement of Feasibility and Acceptability Aim 1 Exit surveys administered via REDCap will be used to assess retention and self-reported empowerment activity participation ie total hours types of eventsactivities roles played73 This will be cross-referenced with research project records of empowerment activity participation Perceptions of the intervention will be qualitatively assessed by interviewing participants over Zoom video chat at 12 weeks post-quit-date PI McQuoid a qualitative methods expert will train a team to conduct semi-structured in-depth interviews lasting approximately 60 minutes Rich content will be elicited regarding experiences of empowerment activity participation and tobacco cessation as an SGM person in Oklahoma Interview guide domains will include i best intervention aspects eg highlights peak experiences ii biggest challenges or negative experiences iii empowerment activity experiences iv interactions of empowerment activity participation with tobacco cessation experiences v outcomes and personal growth vi suggestions for intervention improvements Interviews will be audio-recorded and professionally transcribed verbatim
Qualitative Analysis Dedoose qualitative data analysis software will be used to conduct an inductive-deductive thematic transcript analysis with a priori themes derived from ET39-4245-4773 and SGM tobacco cessation literature33-35 An iterative codebook development process will be used involving weekly team discussions independent coding and member checking of findings74 to enhance rigor and trustworthiness7576 Freedom Oklahoma staff will also be interviewed about their perceptions of the intervention and their organizations role in it
Measurement of Individual Empowerment and Cessation Predictors Aim 2 Individual empowerment and cessation predictors pre- and post-intervention will be compared with baseline and exit surveys Predictors of smoking cessation51-547778 and individual empowerment outcome measures will be compared adapted from a youth empowerment tobacco control model4273 and SGM social change mobilization participation research48 These will include i adaptive coping strategies Cognitive Emotion Regulation Questionnaire79 ii v social support Relational Health Indices80 iii abstinence self-efficacy Confidence Inventory81 and iv internalized SGM stigma Internalized Transphobia and Pride82 and Internalized Homophobia items83
Measurement of Tobacco Cessation Outcomes Aim 3 Benchmarks will be used to assess participants tobacco cessation outcomes Tobacco abstinence will be measured via self-report and biochemically-verified via expired carbon monoxide at baseline and 12 weeks post-quit-date Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire MAQ84 and counseling session attendance tracking
Sample SizeAnalysis Plan Primary outcome variables will be retention perceptions of the intervention adaptive coping strategies biochemical verification of tobacco abstinence at 12 weeks post-quit-date and treatment adherence Retention will be evaluated by calculating the proportion of participants who complete the final study visit at 12-weeks post-quit with the goal of retaining 80 of participants Perceptions of the intervention will be qualitatively evaluated as described above A two-sided paired samples t-test will be used to examine the mean differences in adaptive coping strategies pre- and post-intervention α005 Assuming 20 attrition and a standard deviation of differences of 4085 n20 participants will provide 80 power to detect a mean difference of 26 in adaptive coping strategies Tobacco cessation outcomes will be considered successful if the proportion of participants with biochemically-verified smoking abstinence expired carbon monoxide at 12 weeks post-quite-date is equal to or greater than the general TTRP sample ie 18 at 12 weeks1 Treatment adherence will be considered successful with all participants having 50 of treatment weeks with an MAQ score indicating moderatehigh adherence and counseling session attendance
Expected outcomes Empowerment-enhanced tobacco cessation assistance will be acceptable and feasible Aim 1 will increase within-subject empowerment and improve cessation predictors Aim 2 and will meet benchmarks for tobacco cessation outcomes Aim 3
Aim 2 Compare individual empowerment and cessation predictors pre- and post-intervention Hypothesis Post intervention participants will have i increased adaptive coping strategies social support and smoking abstinence self-efficacy and ii decreased internalized SGM stigma
Aim 3 Assess tobacco cessation outcomes post-intervention Hypothesis The proportion of participants with biochemically-verified smoking abstinence at 12 weeks post-quit-date will be equal to or greater than the general Stephenson Cancer Center Tobacco Treatment research Program TTRP intervention ie 18 biochemically-verified abstinence at 12 weeks1 medication and counseling adherence will be moderateoptimal for 50 of treatment weeks
Study overview This study will assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for SGM adults A single-arm pilot design will be used given funding time and sampling pool limits Participants N20 will receive standard TTRP tobacco cessation assistance and concurrently participate in SGM empowerment activities Outcomes will be assessed quantitatively and qualitatively Primary outcome variables will be retention perceptions of the intervention adaptive coping strategies biochemically-verified smoking abstinence at 12 weeks post-quit-date and treatment adherence
Recruitment Participants will be enrolled over a 4-month period and recruit through the TTRP which serves an average of 30 SGM individuals per year without SGM-targeted recruitment This will be supplement by recruiting via local SGM-serving organizations SGM targeted social media ads eg Facebook and snowball recruitment
Intervention Participants will receive standard TTRP tobacco cessation assistance either remotely or in-person 6 weekly counseling sessions and 12 weeks of combination NRT nicotine patches nicotine gum or lozenges During the 6 weeks of counseling participants will also engage in at least 4 empowerment activities ie SGM social change mobilization and community-building activities48 for a total of at least 8 hours Activities will be tailored to each participants comfort level and provide COVID-19 risk-reduction options eg remote or masked outdoor activities Examples are i running tobacco-free Pride events that occur in Jun and Oct in OK ii organizing a virtual SGM town hall to inform the OK State Plan on Aging iii SGM-relevant legislative phone banking eg regarding transgender student participation in school athletics and iv follow-up surveying of Freedom OKs name and gender marker change clinic72 participants
Participants will complete the following assessments i 8 surveys baseline exit quit-day 1-4 and 12 weeks post-quit-date ii biochemically-verified smoking status at baseline and 12 weeks post-quit-date via expired carbon monoxide monitors and iii a 60-minute in-depth interview over Zoom video chat within weeks 6-8 post-quit-date Participants will be incentivized a total of 200 for the baseline survey 25 6 subsequent surveys 70 2 expired carbon monoxide tests 20 exit survey 25 and 60-minute interview 60 Freedom Oklahoma staff will participate in interviews and reflect on the intervention and Freedom OKs role in it Freedom Oklahoma will adopt a tobacco-free policy and provide feedback on the cultural competence of TTRP materials
Partnerships TTRP will provide the standard tobacco cessation assistance Freedom Oklahoma will design the empowerment activities Freedom Oklahoma is a community-based organization in Oklahoma City that has worked to secure lived equality and legal protection for SGM Oklahomans for over 15 years PI McQuoid and Freedom OK have held more than 4 project planning meetings over the past year
Measurement of Feasibility and Acceptability Aim 1 Exit surveys administered via REDCap will be used to assess retention and self-reported empowerment activity participation ie total hours types of eventsactivities roles played73 This will be cross-referenced with research project records of empowerment activity participation Perceptions of the intervention will be qualitatively assessed by interviewing participants over Zoom video chat at 12 weeks post-quit-date PI McQuoid a qualitative methods expert will train a team to conduct semi-structured in-depth interviews lasting approximately 60 minutes Rich content will be elicited regarding experiences of empowerment activity participation and tobacco cessation as an SGM person in Oklahoma Interview guide domains will include i best intervention aspects eg highlights peak experiences ii biggest challenges or negative experiences iii empowerment activity experiences iv interactions of empowerment activity participation with tobacco cessation experiences v outcomes and personal growth vi suggestions for intervention improvements Interviews will be audio-recorded and professionally transcribed verbatim
Qualitative Analysis Dedoose qualitative data analysis software will be used to conduct an inductive-deductive thematic transcript analysis with a priori themes derived from ET39-4245-4773 and SGM tobacco cessation literature33-35 An iterative codebook development process will be used involving weekly team discussions independent coding and member checking of findings74 to enhance rigor and trustworthiness7576 Freedom Oklahoma staff will also be interviewed about their perceptions of the intervention and their organizations role in it
Measurement of Individual Empowerment and Cessation Predictors Aim 2 Individual empowerment and cessation predictors pre- and post-intervention will be compared with baseline and exit surveys Predictors of smoking cessation51-547778 and individual empowerment outcome measures will be compared adapted from a youth empowerment tobacco control model4273 and SGM social change mobilization participation research48 These will include i adaptive coping strategies Cognitive Emotion Regulation Questionnaire79 ii v social support Relational Health Indices80 iii abstinence self-efficacy Confidence Inventory81 and iv internalized SGM stigma Internalized Transphobia and Pride82 and Internalized Homophobia items83
Measurement of Tobacco Cessation Outcomes Aim 3 Benchmarks will be used to assess participants tobacco cessation outcomes Tobacco abstinence will be measured via self-report and biochemically-verified via expired carbon monoxide at baseline and 12 weeks post-quit-date Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire MAQ84 and counseling session attendance tracking
Sample SizeAnalysis Plan Primary outcome variables will be retention perceptions of the intervention adaptive coping strategies biochemical verification of tobacco abstinence at 12 weeks post-quit-date and treatment adherence Retention will be evaluated by calculating the proportion of participants who complete the final study visit at 12-weeks post-quit with the goal of retaining 80 of participants Perceptions of the intervention will be qualitatively evaluated as described above A two-sided paired samples t-test will be used to examine the mean differences in adaptive coping strategies pre- and post-intervention α005 Assuming 20 attrition and a standard deviation of differences of 4085 n20 participants will provide 80 power to detect a mean difference of 26 in adaptive coping strategies Tobacco cessation outcomes will be considered successful if the proportion of participants with biochemically-verified smoking abstinence expired carbon monoxide at 12 weeks post-quite-date is equal to or greater than the general TTRP sample ie 18 at 12 weeks1 Treatment adherence will be considered successful with all participants having 50 of treatment weeks with an MAQ score indicating moderatehigh adherence and counseling session attendance
Expected outcomes Empowerment-enhanced tobacco cessation assistance will be acceptable and feasible Aim 1 will increase within-subject empowerment and improve cessation predictors Aim 2 and will meet benchmarks for tobacco cessation outcomes Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None