Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145763
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-11-17
Brief Title:
A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives A Full-Scale Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 clinical trial compares a new smoking cessation smartphone application app iCanQuit to an existing smarphone app National Cancer Institute NCI QuitGuide for helping American Indians and Alaska Natives AIANs quit smoking Compared to other racialethnic groups AIANs have 6 times higher rates of developing smoking-related cancers including lung cancer Commercial cigarette smoking accounts for half of all deaths among AIANs nationwide AIANs often lack of access to smoking cessation interventions which may be due to inequities in the healthcare system lack of health insurance living in rural areas systemic racism and historical trauma There is also a lack of effective smoking cessation interventions for AIANs Smartphone apps have the potential to deliver a low-cost smoking cessation intervention with wide reach to AIANs Apps require no in-person delivery and no provider training do not require integration into complex hospital systems can be freely accessed on an app store and are available at any time and any place iCanQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges staying motivated and preventing relapse The iCanQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking
Detailed Description:
OUTLINE Participants are randomized to 1 of 2 arms
ARM I Participants use the iCanQuit app which includes setting up a personalized quit plan participating in eight levels of the content receiving on-demand help in coping with smoking urges and tracking their daily smoking behaviors for at least 45 days on study
ARM II Participants use the NCI QuitGuide app for at least 45 days on study
After completion of study intervention patients are followed up at 3 6 and 12-months
ARM I Participants use the iCanQuit app which includes setting up a personalized quit plan participating in eight levels of the content receiving on-demand help in coping with smoking urges and tracking their daily smoking behaviors for at least 45 days on study
ARM II Participants use the NCI QuitGuide app for at least 45 days on study
After completion of study intervention patients are followed up at 3 6 and 12-months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09049 | REGISTRY | None | None |
| RG1123796 | OTHER | None | None |
| R01CA284687 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchR01CA284687 |