Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT03669120
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.
Detailed Description:
PRIMARY OBJECTIVES:
I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus \[vs.\] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.
SECONDARY OBJECTIVES:
I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.
EXPLORATORY OBJECTIVES:
I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.
ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.
After completion of study, participants are followed up at 3 and 6 months.
I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus \[vs.\] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.
SECONDARY OBJECTIVES:
I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.
EXPLORATORY OBJECTIVES:
I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.
ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.
After completion of study, participants are followed up at 3 and 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01821 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2016-0564 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |