Web-based Smoking Cessation Program for Tribal College Students

NCT02050308 | Completed Phase 3 Results

• 2 other identifiers: 13613R01CA174481
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 7-day Point Prevalence Abstinence

  self-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up.

  6 months

Secondary Outcomes (3)

• Cigarettes Per Day

  Change from Baseline in number of cigarettes smoked daily at 6 months

• Number of Quit Attempts

  6 months

• Number of Participants Who Participated in All Sessions Over the Course of 6 Months.

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Internet-All Nations Breath of Life (I-ANBL); Drug: Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®

Honoring the Gift of Heart Health

ACTIVE COMPARATOR

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.

Other: Honoring the Gift of Heart Health; Drug: Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®

Interventions

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

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

Honoring the Gift of Heart Health 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.

Honoring the Gift of Heart Health

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

Also known as: Nictotine Replacement Therapy (Nicotine gum, Patch, or Lozenge) or Pharmacotherapy (Zyban® or Chantix®)

Honoring the Gift of Heart Health; Internet-All Nations Breath of Life (I-ANBL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Won Choi, PhD, MPH: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Salish Kootenai College

Pablo, Montana, 59855, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Chewing Gum; Transdermal Patch; Bupropion; Varenicline; Drug Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Equipment and Supplies; Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Significant loss to follow-up, lower than expected salivary collection rates, and lower long-term retention of participants.

Results Point of Contact

• Title: Dr. Won S. Choi
• Organization: The University of Kansas Medical Center

wchoi@kumc.edu

(913) 588-4742

Study Officials

• Won Choi, PhD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: May 1, 2015
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 7, 2021
• Results First Posted: August 6, 2019

Record last verified: 2021-11

Locations

US (2)