NCT01310842

Brief Summary

The goal of this study is to learn about the influence of the social and physical environment on smoking cessation (quitting smoking) among smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

February 21, 2011

Last Update Submit

October 3, 2016

Conditions

Smoking Cessation

Keywords

SmokerSmoking CessationSocial DeterminantsEnvironmental EffectsIndividual-level effectsNicotine patchSmart PhoneSPGlobal Positioning SystemGPSQuestionnairesSaliva samples

Outcome Measures

Primary Outcomes (1)

  • Influence of Social and Physical Environment on Smoking Cessation Among Smokers

    Participants followed from 2 weeks prior to quit date through 26 weeks after quit date, assessed for 4 contiguous weeks (1 week precessation through 3 weeks postcessation) using state-of-the-science ecological momentary assessment (EMA) and global positioning system (GPS) procedures.

    3 weeks

Study Arms (2)

Pilot Smoking Cessation

4 weeks nicotine patch therapy, self-help materials, and 5 in-person counseling sessions.

Behavioral: QuestionnairesDrug: Nicotine Patch TherapyBehavioral: Counseling Sessions

Smoking Cessation

4 weeks nicotine patch therapy, self-help materials, and 7 in-person counseling sessions.

Behavioral: QuestionnairesDrug: Nicotine Patch TherapyBehavioral: Counseling Sessions

Interventions

QuestionnairesBEHAVIORAL

Questionnaires completed at each study visit, taking 60-90 minutes, in addition to 4 Smart Phone initiated assessments per day during waking hours, taking about 5-10 minutes.

Also known as: Survey
Pilot Smoking CessationSmoking Cessation
Nicotine Patch TherapyDRUG

4 weeks of nicotine patch therapy

Pilot Smoking CessationSmoking Cessation
Counseling SessionsBEHAVIORAL

5 or 7 in person counseling sessions on smoking cessation: Baseline, Week 0/Quit Date (1 week following the baseline visit), Week 1, Week 2, Week 3 for Pilot Group and additional sessions Week 12 and Week 26 for other group.

Pilot Smoking CessationSmoking Cessation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current smoker, age 18 years or above, with a history of at least 5 cigarettes/day for the last year and resides in Houston, Texas.

You may qualify if:

  • and above
  • Current smoker with a history of at least 5 cigarettes/day for the last year (participant must register a CO level of 8 or higher)
  • Motivated to quit within the next 30 days
  • Valid home address reflective of residence in Houston
  • Functioning telephone number
  • Can speak, read, and write in English
  • Marginal or adequate health literacy

You may not qualify if:

  • Contraindication for nicotine patch use
  • Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
  • Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
  • Pregnancy or lactation
  • Another household member is enrolled in this protocol
  • Active substance abuse problem
  • Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples at Baseline, week 12, and week 26 visits collected for cotinine tests.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Larkin L. Strong, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

March 9, 2011

Study Start

July 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

US(1)