Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03316170
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2017-09-26
Brief Title:
Consultation Advice and Tailored Support CATS for Cancer Survivors
Sponsor:
Jessica Burris
Organization:
University of Kentucky
Study Overview
Official Title:
Consultation Advice and Tailored Support CATS for Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2021-06
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 objectives of this pilot clinical trial are 1 To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources and 2 To assess the effectiveness of said treatment for key events in the process of smoking cessation
Detailed Description:
This is a pilot Phase II randomized clinical trial with randomization in a 11 ratio The control group will receive a brief consultation 10-15 minutes via phone about free or low-cost resources that may help them address unmet social support needs Additionally a written directory of a range of social support resources will be delivered to them via mail The treatment group will receive the aforesaid intervention plus brief advice to quit smoking 10-15 minutes via phone Additionally a written summary of the benefits of smoking cessation evidence-based approaches to quit and the basics of nicotine replacement therapy NRT will be provided via mail The treatment group will also receive a free 2-week supply of nicotine patches and lozenges delivered via mail As a pilot this study focuses on the outcomes of feasibility ie accrual and retention and acceptability eg participants perceptions of appropriateness and effectiveness as opposed to efficacy though this is also important The emphasis on smoking cessation induction that is the inducement or promotion of a quit attempt is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None