Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05365633 |
| Other study ID # |
14472 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
January 11, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sexual and/or 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 one's 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 N=20 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 PI's 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.
Description:
Aim 1: Assess the feasibility and acceptability of empowerment-enhanced tobacco cessation
assistance for sexual and/or gender minority (SGM) adults. Use baseline and exit surveys and
in-depth interviews to assess retention, empowerment activity participation (e.g., 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 (i.e., 18% biochemically-verified abstinence at 12 weeks1);
medication and counseling adherence will be moderate/optimal 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 (N=20) 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 (e.g., 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' (i.e., SGM social change mobilization and
community-building activities48) for a total of at least 8 hours. Activities will be tailored
to each participant's comfort level and provide COVID-19 risk-reduction options (e.g., 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 (e.g., regarding transgender student
participation in school athletics); and (iv) follow-up surveying of Freedom OK's 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 OK's 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 (i.e.,
total hours, types of events/activities, roles played).73 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 (e.g. 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
ET39-42,45-47,73 and SGM tobacco cessation literature.33-35 An iterative codebook development
process will be used involving weekly team discussions, independent coding, and member
checking of findings74 to enhance rigor and trustworthiness.75,76 Freedom Oklahoma staff will
also be interviewed about their perceptions of the intervention and their organization's 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 cessation51-54,77,78 and individual
empowerment outcome measures will be compared, adapted from a youth empowerment tobacco
control model42,73 and SGM social change mobilization participation research.48 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 (MAQ)84 and counseling session attendance tracking.
Sample Size/Analysis 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
(α=0.05). Assuming 20% attrition and a standard deviation of differences of 4.085, n=20
participants will provide 80% power to detect a mean difference of 2.6 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 (i.e., 18% at 12
weeks1). Treatment adherence will be considered successful with all participants having >50%
of treatment weeks with an MAQ score indicating moderate/high 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).
