Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers

Tobacco Use Cessation Clinical Trial

Official title:

Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811628
• Other study ID #: 2012-1051
• Secondary ID: K01CA160670
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: July 17, 2017
• Start date: July 17, 2013
• Est. completion date: July 14, 2017

Study information

• Verified date: July 2017
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research study is to collect information from Latino and Hispanic smokers and recent quitters about factors that are important to them when they are trying to quit. Researchers want to better understand some of the challenges and problems that Latinos and Hispanics face when they try to quit smoking, and then use that information to design a treatment for future smokers.

Description:

If participant decides to take part in this study, they will complete a questionnaire about themselves (such as their age, preferred language, and education level) and their smoking habits. This questionnaire should take about 10-15 minutes to complete.

After participant completes this questionnaire, they will be interviewed by a researcher. During this interview participant will be asked to discuss a variety of topics related to smoking and quitting, such as their experience with attempts to quit smoking and problems they may have had. This interview will last about 1 hour.

The interview will be audio-recorded. Participant's interview answers will later be transcribed (written down) without their name or any other identifying information.

Study participation will be complete after the interview.

This is an investigational study.

Up to 48 people will be enrolled in this study. All will take part at MD Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18+ years of age

2. Current smoker (>10 cigarettes per day for the past 3 months) or recently quit Smoking (within the past year) but has not smoked for the past 2 months)

3. Read, understand and speak Spanish

4. Identify as being of Latino (or Hispanic) heritage, ethnicity, or ancestry.

Exclusion Criteria:

1. The self-report of a diagnosis of Schizophrenia, Delusional Disorder, Schizoaffective Disorder or Bipolar Disorder in the past year.

2. The self-report of a diagnosis of a Substance Dependence Disorder other than Nicotine in the past year (i.e., Alcohol Dependence, Amphetamine Dependence, Cannabis Dependence, Cocaine Dependence, Hallucinogen Dependence, Inhalant Dependence, Opioid Dependence, Phencyclidine Dependence, Sedatives, Hypnotics, or Anxiolytic Dependence, or Polysubstance Dependence)

3. Unavailable for a 1.5 hour visit to MD Anderson Cancer Center.

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Questionnaire
Questionnaire completion taking about 10-15 minutes.
• Interview
Audio-recorded interview that will last about 1 hour.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information Collection From Latino and Hispanic Smokers or Recent Quitters	Primary aim of this study is to conduct in-person qualitative interviews with 48 Latino smokers or recent quitters in order to gather information regarding potential elements to include in a future intervention that will target smoking cessation treatment adherence among Latino smokers. This exploratory and qualitative study will utilize thematic analyses of interview discussions to analyze and derive elements that will ultimately be included in a treatment manual.; Data analyzed using thematic analysis, enabling recurring themes from the data presented and discussed and opposing cases highlighted. Analyses facilitated by the use of N*Vivo - a software package package specific to qualitative research. A qualitative analyses of the content of the qualitative interviews conducted separately for current smokers and recent quitters.	1 day

External Links

•   University of Texas MD Anderson Cancer Center website