Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 5:04 AM
Study NCT ID:
NCT01352195
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Self-Help for Smoking Cessation
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
Extended Self-Help for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.
Detailed Description:
The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: