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.