Web-based Smoking Cessation Program for Tribal College Students

NCT ID: NCT02050308

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-03-31

Brief Summary

The purpose of this study is to test the effectiveness of a culturally-tailored Internet-based program that helps American Indian (AI) tribal college students quit smoking.

Detailed Description

Many of the approximately 25,000 American Indian (AI) students enrolled in tribal colleges/universities in the US arrive there as smokers. A 2011 study of high school seniors reported that the smoking prevalence among AI students is approximately 40%, the highest rate among all racial and ethnic groups studied. Although prevalence data on smoking among AI college students are limited, studies have shown that the majority of smokers in high school continue to smoke once they reach college. Prohibited from marketing to adolescents and children, the tobacco industry in recent years has shifted its most intense marketing to college students, resulting in increases in smoking rates among them. The transition to college provides amble opportunities for young adults to acquire new and harmful habits. Many of these habits do not seem so alien to young AIs: Cigarette smoking is the number one cause of preventable death among AIs. Cancer is the second leading cause of death among AIs, and lung cancer is the leading cause of cancer deaths for both AI men and women. Cultural factors, socioeconomic circumstances, and lack of culturally-tailored cessation programs for American Indian tribal college students have prevented access to effective interventions that promote smoking cessation. To date, few studies have focused on methods to encourage smoking cessation among tribal college students and no randomized clinical trials have yet been conducted. To address this public health deficit, we propose an innovative, effective, culturally and individually-tailored smoking cessation programs to promote cessation.

Primary aim is to: To test the effectiveness of a culturally-tailored internet-based smoking cessation intervention (I-ANBL) compared to an internet-based heart healthy diet (I-FV:fruit/vegetable) control condition in a randomized controlled trial with Tribal College students. Our hypothesis is that American Indian tribal college students randomized to the culturally-tailored smoking cessation arm will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days, biochemically verified) rates at 6 months than those receiving the heart healthy diet intervention.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Internet-All Nations Breath of Life (I-ANBL)

The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to quitting smoking (like: preparing to quit, dealing with cravings, and support systems, etc.) and topics relevant to American Indian culture (like traditional use of tobacco).

We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use.

Group Type: EXPERIMENTAL

Internet-All Nations Breath of Life (I-ANBL)

Intervention Type: OTHER

• Participants will be asked to log into the website prior to the first session to allow for any problems with the site to be fixed prior to sessions starting. Topics we anticipate covering include, but are not limited to: preparing to quit, dealing with cravings, support systems, traditional tobacco, stress reduction, weight management, and staying quit, along with other topics determined during program development. For each session, the tribal college student will begin the session by answering a series of questions to produce an individually-tailored report that will be provided on the screen at the end of each week's session so that the smoker can work on strategies during the week before the next internet session
• Weekly procedures will follow the same format as for the first session

Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®

Intervention Type: DRUG

Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.

Honoring the Gift of Heart Health

The culturally-tailored program includes 9 individual Internet-based sessions across a 12 week period and an additional individual Internet-based session at 6 months. Web sessions will last about half-an-hour (30 minutes) and will discuss topics that are important to heart health (like: Assessing risk for heart disease, increasing fruit and vegetable consumption, physical activity, etc.).

We plan to give participants in our cessation program a choice of varenicline, bupropion, nicotine replacement therapy or no pharmacotherapy. We choose to give our participants a choice because our experience shows that we would be unlikely to recruit AI participants into a trial that requires pharmacotherapy use.

Group Type: ACTIVE_COMPARATOR

Honoring the Gift of Heart Health

Intervention Type: OTHER

These sessions help American Indians learn about what they can do to prevent heart disease. We will emphasize the increase consumption of fruits and vegetables as well as addressing other heart healthy activities. Honoring the Gift of Heart Health is a user-friendly program developed especially for American Indians. The manual provides the "how-to" for leading group education sessions. It offers "hands-on" activities that help people build the skills they need to make simple, practical, and lasting changes to help them fight heart disease. The protocol will follow procedures as the I-ANBL arm, however, this fruit and vegetable arm will not include individually tailored components, but just interactive web-based materials related to increasing heart health, including certain activities.

Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®

Intervention Type: DRUG

Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.

Interventions

Internet-All Nations Breath of Life (I-ANBL)

• Participants will be asked to log into the website prior to the first session to allow for any problems with the site to be fixed prior to sessions starting. Topics we anticipate covering include, but are not limited to: preparing to quit, dealing with cravings, support systems, traditional tobacco, stress reduction, weight management, and staying quit, along with other topics determined during program development. For each session, the tribal college student will begin the session by answering a series of questions to produce an individually-tailored report that will be provided on the screen at the end of each week's session so that the smoker can work on strategies during the week before the next internet session
• Weekly procedures will follow the same format as for the first session

Intervention Type: OTHER

Honoring the Gift of Heart Health

These sessions help American Indians learn about what they can do to prevent heart disease. We will emphasize the increase consumption of fruits and vegetables as well as addressing other heart healthy activities. Honoring the Gift of Heart Health is a user-friendly program developed especially for American Indians. The manual provides the "how-to" for leading group education sessions. It offers "hands-on" activities that help people build the skills they need to make simple, practical, and lasting changes to help them fight heart disease. The protocol will follow procedures as the I-ANBL arm, however, this fruit and vegetable arm will not include individually tailored components, but just interactive web-based materials related to increasing heart health, including certain activities.

Intervention Type: OTHER

Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®

Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.

Intervention Type: DRUG

Other Intervention Names

Nictotine Replacement Therapy (Nicotine gum, Patch, or Lozenge) or Pharmacotherapy (Zyban® or Chantix®)

Eligibility Criteria

Inclusion Criteria

• Currently enrolled at Salish Kootenai College
• Have a valid telephone number and email address
• Willing to participate in all study components
• Willing to be followed-up for 6 months
• Self identifies as American Indian or Alaska Native
• Is a current smoker

Exclusion Criteria

• Planning to leave college within next 6 months
• Medically ineligible as a result of screening questions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Won Choi, PhD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Won Choi, PhD, MPH

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Won Choi, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Salish Kootenai College

Pablo, Montana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01CA174481

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13613

Identifier Type: -

Identifier Source: org_study_id