Tobacco Cessation Clinical Trial
Official title:
NIH-NCI U54 University of Guam/Cancer Center of Hawaii Partnership Full Project II: The Betel Nut Intervention Trial
Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive
substance in the world, following only alcohol, nicotine, and caffeine in prevalence of
consumption. Although betel nut is chewed by approximately 600 million people globally, its
use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has
been classified as a Group 1 carcinogen by the International Agency for Research on Cancer.
Despite the global significance and carcinogenicity of betel nut, there has been very little
behavioral or psychological research about betel nut chewing, and there has been no
systematic research on the topic of betel nut cessation interventions. The current
intervention builds directly upon the National Institutes of Health - National Cancer
Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive
Partnership to Advance Health Equity. Previous data collected through the partnership suggest
that betel nut chewers, like smokers, generally want and intend to quit, but do not have
specific plans of how or when they will quit. In addition, most betel nut chewers in the
partnership's previous study already have tried to quit on one or more occasions. The
findings suggest that betel nut chewers could benefit from cessation programs modeled after
smoking cessation programs. During 2014, partnership investigators conducted a feasibility
study of the betel nut cessation program. The program was well received and yielded
surprisingly high rates of self-reported betel nut cessation.
Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation program.
Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut
cessation intervention trial using bio-verification.
The general framework employed to guide the intervention is cognitive-behavioral therapy. The
cognitive-behavioral therapy is goal-oriented and problem-focused. The goal of the
intervention is to help betel nut chewers to quit chewing betel nut using structured
sessions. The cognitive component addresses chewers' attitudes and beliefs about betel nut
chewing. Preliminary data from a feasibility study revealed that most participants initially
underestimated such negative health effects of betel nut. The behavioral component of the
intervention aims to replace chewing-promoting behaviors with behaviors that are more
conducive to quitting betel nut and staying quit, and preparing responses for social
situations where pressure to chew is likely to occur.
The structure of the proposed betel nut cessation program is modeled after a specific
group-based cognitive-behavioral smoking cessation program. The program was selected because
it is a well-established and evidence-based group cessation program. The intervention will
consist of a 22-day, five-session support and informational group program. Betel nut use will
be evaluated via surveys and bio-verification at three points: at the initial group meeting,
at the final group meeting, and six months following the final group meeting.
Group Intervention Format and Procedures
Five group sessions will be conducted over a period of 22 days per cohort. Group meetings
will be approximately one hour in length and will be conducted by study investigators and
staff. Surveys will be administered at the first and last group meetings, as well as six
months after the last meeting. Surveys will be self-administered at the beginning of the
intervention sessions. Confidentiality will be emphasized at all meetings, but especially so
in the first session, and will be addressed specifically in the informed consent document.
Participants will be reminded that participation is completely voluntary and that withdrawal
without penalty is always an option. At most sessions, handouts will be provided and topical
"homework" will be distributed.
Saliva Samples
Saliva samples (ca. 1-2 mL) for intervention condition participants will be collected at the
same times as the three survey assessments (baseline, the final group intervention session,
and the six-month follow-up). Saliva samples for control condition participants (also ca. 1-2
mL) will be collected on the same schedule as the intervention condition participants. From
the saliva samples, Dr. Adrian Franke's laboratory will measure by liquid chromatography mass
spectrometry levels of salivary biomarkers previously identified in the pilot study, which
identified compounds specific for areca nuts and betel leaves that were extracted while
chewing three different betel preparations. The studies also revealed that the compounds are
secreted into saliva and appear in chewers' saliva up to eight hours after the chewing event.
To verify self-reports of betel nut abstinence, the investigators will set cut-offs for
levels of alkaloids specific for areca nuts as follows: arecoline 60 ng/mL, arecaidine 10
ng/mL, guvacoline 20 ng/mL, and guvacine 6 ng/mL). Levels above the values will indicate
evidence of recent betel nut consumption. Participants whose saliva tests reveal values above
the specified cut-offs will be considered current chewers for the purposes of bio-verified
outcomes (i.e., chewer or non-chewer status). The biomarker results will be used to compare
self-reports of recent chewing behavior (amount and recency) with biomarker data to assess
dose-response effects.
Saliva samples will be collected in Guam and Saipan in 20 mL conical polypropylene tubes
which will be initially stored at -20°C. Aggregated samples will be shipped to Hawaii via
FedEx. Shipments will be performed whenever 50-60 samples are successfully collected. After
arriving in Hawaii, samples will be stored in Dr. Adrian Franke's lab at -80°C until
analysis. All samples available at Dr. Adrian Franke's lab will be analyzed in one batch at
the end of each annual cycle of the study.
Survey Assessments
Baseline Survey
The baseline survey will be administered during the first group session. Saliva samples will
be collected.
First Follow-Up Survey
The first follow-up survey will be administered during the final group session. Participants
will indicate any attempt to quit chewing betel nut since starting the intervention program,
current chewing status (chewer or ex-chewer), number of group sessions attended (and reasons
for absence, if applicable), and quid composition (if still chewing). The participants will
also be asked several questions to measure satisfaction with the cessation program. Saliva
samples will be collected for a second time.
Second Follow-Up Survey
Six months post-cessation, participants will arrange to meet with study staff to complete a
final survey assessment. Participants will be asked again to evaluate the program, as well as
follow-up questions regarding current chewing status and betel quid composition. Saliva
samples will be collected for a final time.
Measurement of Cessation Outcomes
Primary cessation outcomes will be assessed by self-reported 7-day point prevalence
abstinence bio-verified by the saliva tests. Participants who self-report chewing cessation
but who test positive for the betel nut biomarker will be classified as chewers.
Data Analysis
The data analysis plan was designed under the direct guidance of the U54 Biostatistics Core.
The goal of the analysis is to determine if the proposed intervention strategy affects
cessation of betel nut chewing. Information on chewing behavior will be collected at
baseline, month 1, and month 6 for the intervention (IN0, IN1, IN6) and control conditions
(C0, C1, C6). The efficacy of the cessation program will be assessed by estimation and
comparison of cessation prevalence over time, defined as the proportion who are not chewing
betel nut. The first test of efficacy will compare the cessation status between randomization
groups at month 1 and month 6, using a logistic mixed model, which will account for the
repeated (correlated) measures within each individual. The independent variables will include
randomization group (defined as intent-to- treat), time (parameterized as two indicator
variables), location (Guam/Saipan), and interaction terms between group and time. Potential
confounders, such as gender, ethnicity and age, will be added to the models. The F-test for
the interaction term for 6 months will be the test of efficacy. Statistics of interest from
the model include the odds ratio and 95% confidence interval (CI) comparing randomization
groups, and the covariate-adjusted probabilities of cessation and their 95% CIs, predicted by
group from the model. The data will be analyzed within subgroups, such as location (Guam or
Saipan) to provide information on whether the intervention was more effective in select
groups. The investigators will model treatment as the number of sessions attended to
determine if the program was more effective in more compliant participants. The mixed model
uses all available data points at each time point. If there is evidence of non-random
missingness, such as by differential drop-out between groups, multiple imputation will be
used to determine if missing data led to biased results.
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