Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00850954
Other study ID # 2006-0440
Secondary ID NCI-2019-0250220
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2006
Est. completion date August 7, 2018

Study information

Verified date June 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies the effect of an intervention program, Project CASA, on smoking cessation and reducing secondhand smoke exposure in Mexican American households. Project CASA, comprising pamphlets and fotonovelas (illustrated storybooks), may provide valuable information to participants on how to improve the air quality in their homes.


Description:

PRIMARY OBJECTIVES: I. Reduction in secondhand smoke exposure: The study will distinguish if a tailored intervention designed to address the needs of the target group will reduce objectively and subjectively measured secondhand smoke exposure of nonsmokers in Mexican American (MA) households. Ia. Develop tailored fotonovelas for intervention implementation. II. Smoking cessation: The study will identify if a tailored intervention designed to address the needs of the target group will help the primary smokers in the household quit smoking. III. Stages of change: The study will identify if the proposed intervention will have a significant impact on the primary smoker(s) progression through the stages of smoking cessation. IV. Knowledge and attitudes: The study will identify if the proposed intervention will result in better knowledge and changed attitudes towards secondhand smoke exposure among members of MA households (smokers and nonsmokers) compared to standard care. V. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke would improve perceived health. OUTLINE: Participants are assigned to 1 of 2 groups based on smoking status. GROUP I (SMOKERS): Participants receive smoking cessation intervention materials based on transtheoretical model of change (TTM). GROUP II (NON-SMOKERS): Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting. Participants are followed up at 6 and 12 months to assess for home air quality.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date August 7, 2018
Est. primary completion date August 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Live in the targeted Mexican American neighborhoods. - Can read Fotonovelas in English and Spanish. - Access to telephone. - Smoker in household (adult [18+] person living in the household who smokes INSIDE at least one cigarette a week).

Study Design


Intervention

Other:
Informational Intervention
Receive information on secondhand smoke and supporting smoker in quitting
Behavioral:
Smoking Cessation Intervention
Receive smoking cessation materials based on TTM
Other:
Survey Administration
Ancillary studies

Locations

Country Name City State
United States M D 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 Level of nicotine measured at 6 month post intervention Method of analysis is a pre-post test analysis of covariance, ANCOVA, using a linear regression model (PROC REG in SAS). In this analysis, the prevalence of nicotine levels at the 6-month follow-up compared between conditions while controlling for baseline nicotine levels. Second hand smoke (SHS) exposure based on objective monitoring of SHS in each household (in the kitchen and TV room) over a 7-day period. A small, lightweight (16 gram) passive nicotine monitor used to measure exposure to nicotine. 6 months after treatment
See also
  Status Clinical Trial Phase
Completed NCT02169271 - Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules Phase 2
Recruiting NCT03865472 - rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers N/A
Withdrawn NCT03668769 - Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking N/A
Completed NCT02575885 - Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers N/A
Active, not recruiting NCT03900767 - Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment N/A
Recruiting NCT03199651 - Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer N/A
Active, not recruiting NCT01915810 - Physical Activity in Promoting Smoking Cessation in African Americans N/A
Terminated NCT02582008 - Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy Early Phase 1
Recruiting NCT03824535 - 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules Phase 2
Completed NCT02596685 - Effects of Electronic Cigarette Use on the Lungs N/A
Completed NCT04009590 - Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults N/A
Recruiting NCT04376489 - Project MARS: Mobile-Assistance for Regulating Smoking N/A
Withdrawn NCT02591433 - JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer N/A
Completed NCT03808818 - Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices Phase 2