Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00948129
Other study ID # 2009-0336
Secondary ID NCI-2018-0026020
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2009
Est. completion date February 10, 2021

Study information

Verified date January 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.


Description:

PRIMARY OBJECTIVES: I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial. II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence. III. Compare the cost-effectiveness of the three treatment conditions. OUTLINE: Participants are randomized to 1 of 3 groups. GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials. GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks. GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks. After completion of study, participants are followed up at 3, 6, and 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date February 10, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Smoked at least 100 cigarettes in lifetime - English or Spanish speaking - Currently smoking at least 5 cigarettes a day, on average - Willing to set a quit smoking date within a week of the enrollment Exclusion Criteria: - Positive history of a medical condition that precludes use of the nicotine patch - Current use of nicotine replacement therapy (NRT) - Current use of other smoking cessation medications (e.g., Chantix or Zyban) - Pregnant or nursing - Enrolled in another smoking cessation study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Behavioral:
Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Telephone-Based Intervention
Undergo telephone based smoking cessation intervention
Other:
Tobacco Cessation Counseling
Undergo smoking cessation counseling

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 Smoking abstinence rate The primary method of analysis will be mixed-model logistic regression. At 12 months
Primary Cost-effectiveness Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis. At 12 months
Secondary Salivary cotinine levels Salivary cotinine will be measured using the NicAlert test system. At 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT03691350 - Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs Early Phase 1
Completed NCT01967082 - APPSPIRE App in Preventing Students From Smoking N/A
Recruiting NCT03865472 - rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers N/A
Active, not recruiting NCT02271919 - Varenicline and Combined NRT for Smoking Cessation Phase 4
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
Completed NCT04060446 - Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
Completed NCT00941395 - Enhanced Smoking Cessation for University Students 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
Recruiting NCT03824535 - 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules Phase 2
Completed NCT00468234 - Validation of Biomarkers of Exposure and Host Response N/A
Completed NCT00850954 - Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households N/A
Active, not recruiting NCT02697227 - Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation N/A
Completed NCT03669120 - Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking N/A