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Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers

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ClinicalTrials.gov Identifier: NCT00948129
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Current Every Day Smoker Other: Laboratory Biomarker Analysis Behavioral: Smoking Cessation Intervention Behavioral: Telephone-Based Intervention Other: Tobacco Cessation Counseling Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
Actual Study Start Date : August 10, 2009
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group I (standard care)
Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.
Other: Laboratory Biomarker Analysis
Correlative studies

Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Name: Smoking and Tobacco Use Cessation Interventions

Experimental: 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.
Other: Laboratory Biomarker Analysis
Correlative studies

Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Name: Smoking and Tobacco Use Cessation Interventions

Other: Tobacco Cessation Counseling
Undergo smoking cessation counseling

Experimental: 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.
Other: Laboratory Biomarker Analysis
Correlative studies

Behavioral: Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
Other Name: Smoking and Tobacco Use Cessation Interventions

Behavioral: Telephone-Based Intervention
Undergo telephone based smoking cessation intervention

Other: Tobacco Cessation Counseling
Undergo smoking cessation counseling




Primary Outcome Measures :
  1. Smoking abstinence rate [ Time Frame: At 12 months ]
    The primary method of analysis will be mixed-model logistic regression.

  2. Enhanced care (EC) and intensive care (IC) abstinence effect [ Time Frame: Up to 12 months ]
    Structural equation modeling (SEM) will be used to develop a model of the patterns of association among the mediating variables, intervention method and abstinence. This will be done at individual time points as well as longitudinally across time.

  3. Cost-effectiveness [ Time Frame: At 12 months ]
    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.


Secondary Outcome Measures :
  1. Salivary cotinine levels [ Time Frame: At 12 months ]
    Salivary cotinine will be measured using the NicAlert test system.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948129


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alexander V Prokhorov M.D. Anderson Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00948129    
Other Study ID Numbers: 2009-0336
NCI-2018-00260 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2009-0336 ( Other Identifier: M D Anderson Cancer Center )
R01CA141628 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No