NIH-NCI U54 University of Guam/Cancer Center of Hawaii Partnership Full Project II: The Betel Nut Intervention Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Guam
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Change in number of participants who self-report that they quit chewing betel nut to be measured via survey
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Self-described betel nut chewer (chewed betel nut for at least 1 year, and at a rate of at least 3 days per week). Must chew a quid consisting of areca nut, slaked lime, betel leaf, tobacco, and/or other optional ingredients.
- •Age ≥ 18 years
- •Reside in Guam or Saipan
- •Able to understand, speak, and read English
- •Provide signed informed consent and agree to comply with all protocol-specified procedures (e.g., providing saliva samples, participating in five one-hour group sessions over a period of 22 days) and follow-up evaluations
Exclusion Criteria
- •Chews betel nut without tobacco
- •Does not speak, read, and/or write English
- •Women who are pregnant or nursing
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Other illness that in the opinion of the investigator would exclude the patient from participating in this study
Arms & Interventions
Control
Minimal interaction between participant and facilitator regarding cessation strategies. Participants will only be given a betel nut cessation booklet.
Intervention: Betel Nut Cessation Booklet (Behavioral)
Experimental
Intensive 5-session intervention program over the span of 22 days, with an additional follow up session after 6 months. The sessions will utilize betel nut cessation social support groups, as well as interactive discussion on how to quit chewing.
Intervention: Betel Nut Cessation Social Support (Behavioral)
Experimental
Intensive 5-session intervention program over the span of 22 days, with an additional follow up session after 6 months. The sessions will utilize betel nut cessation social support groups, as well as interactive discussion on how to quit chewing.
Intervention: Betel Nut Cessation Booklet (Behavioral)
Outcomes
Primary Outcomes
Change in number of participants who self-report that they quit chewing betel nut to be measured via survey
Time Frame: 6 months
This will measure cessation prevalence (stay-quit) long-term
Change in number of participants who self-report that they quit chewing betel nut to be measured via survey
Time Frame: 22 days
This will measure cessation prevalence immediately after the program
Secondary Outcomes
- Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry(6 months)
- Levels of cotinine and betel nut biomarkers in saliva samples to be tested via liquid chromatography mass spectrometry(22 days)