Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers
Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
3 other identifiers
interventional
626
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
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
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedStudy Start
First participant enrolled
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2021
CompletedJanuary 20, 2023
January 1, 2023
11.5 years
July 14, 2009
January 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Smoking abstinence rate
The primary method of analysis will be mixed-model logistic regression.
At 12 months
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 Outcomes (1)
Salivary cotinine levels
At 12 months
Study Arms (3)
Group I (standard care)
ACTIVE COMPARATORParticipants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.
Group II (enhanced care)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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.
Interventions
Correlative studies
Undergo standard of care smoking cessation intervention
Undergo telephone based smoking cessation intervention
Undergo smoking cessation counseling
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (3)
Vidrine DJ, Frank-Pearce SG, Vidrine JI, Tahay PD, Marani SK, Chen S, Yuan Y, Cantor SB, Prokhorov AV. Efficacy of Mobile Phone-Delivered Smoking Cessation Interventions for Socioeconomically Disadvantaged Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):167-174. doi: 10.1001/jamainternmed.2018.5713.
PMID: 30556832DERIVEDDaly AT, Deshmukh AA, Vidrine DJ, Prokhorov AV, Frank SG, Tahay PD, Houchen ME, Cantor SB. Cost-effectiveness analysis of smoking cessation interventions using cell phones in a low-income population. Tob Control. 2019 Jan;28(1):88-94. doi: 10.1136/tobaccocontrol-2017-054229. Epub 2018 Jun 9.
PMID: 29886411DERIVEDVidrine DJ, Fletcher FE, Danysh HE, Marani S, Vidrine JI, Cantor SB, Prokhorov AV. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION. BMC Public Health. 2012 Aug 25;12:696. doi: 10.1186/1471-2458-12-696.
PMID: 22920991DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander V Prokhorov
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 29, 2009
Study Start
August 10, 2009
Primary Completion
February 10, 2021
Study Completion
February 10, 2021
Last Updated
January 20, 2023
Record last verified: 2023-01