NCT00850954

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2018

Completed
Last Updated

September 28, 2023

Status Verified

June 1, 2022

Enrollment Period

12 years

First QC Date

February 24, 2009

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group I (smoking cessation)

EXPERIMENTAL

Participants receive smoking cessation intervention materials based on TTM.

Behavioral: Smoking Cessation InterventionOther: Survey Administration

Group II (informational)

EXPERIMENTAL

Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting.

Other: Informational InterventionOther: Survey Administration

Interventions

Receive information on secondhand smoke and supporting smoker in quitting

Group II (informational)

Receive smoking cessation materials based on TTM

Also known as: Smoking and Tobacco Use Cessation Interventions
Group I (smoking cessation)

Ancillary studies

Group I (smoking cessation)Group II (informational)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Smoking Devices

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alexander V Prokhorov

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

August 8, 2006

Primary Completion

August 7, 2018

Study Completion

August 7, 2018

Last Updated

September 28, 2023

Record last verified: 2022-06

Locations