Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432985
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-20
Brief Title:
Smoking Cessation CM for Veterans With or at Risk for Cancer
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Contingency Management for Veteran Smokers With or at Risk for Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
CM_TUD_Cancer
Brief Summary:
Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being The aim of this project is to evaluate the effectiveness of a program called Contingency Management CM in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing In the first year the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups In the second year they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period The success of the pilot study will determine whether to proceed with a larger randomized controlled trial RCT in years three to six comparing the efficacy of mobile CM with standard treatment The project will take place at SFVA
Detailed Description:
Smoking at the time of lung cancer screening LCS or cancer diagnosis is associated with treatment failure shortened lifespan and diminished quality of life Beyond the increased morbidity and mortality smoking after a cancer diagnosis is associated with an estimated 34 billion in healthcare costs Despite these risks the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care and quit rates are low
Contingency Management C is a behavioral therapy approach that reinforces desired behaviors such as smoking cessation through the provision of tangible rewards or incentives The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability feasibility and efficacy of Contingency Management CM for smoking cessation among Veterans in lung cancer screening LCS or cancer care in Veterans Affairs VA clinics
Research indicates that CM must be tailored to the clinical population and context This staged investigation will occur in three phases First the investigators will conduct Focus Groups to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff Afterward the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care In a single arm study Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks If successful the investigators will conduct a Randomized Controlled Trial RCT to assess efficacy of mobile CM compared with treatment as usual TAU Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition CM plus behavioral counseling or TAU referral to VA Tobacco Cessation Clinic and VA quitline Both groups will receive pharmacotherapy
The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS
Contingency Management C is a behavioral therapy approach that reinforces desired behaviors such as smoking cessation through the provision of tangible rewards or incentives The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability feasibility and efficacy of Contingency Management CM for smoking cessation among Veterans in lung cancer screening LCS or cancer care in Veterans Affairs VA clinics
Research indicates that CM must be tailored to the clinical population and context This staged investigation will occur in three phases First the investigators will conduct Focus Groups to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff Afterward the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care In a single arm study Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks If successful the investigators will conduct a Randomized Controlled Trial RCT to assess efficacy of mobile CM compared with treatment as usual TAU Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition CM plus behavioral counseling or TAU referral to VA Tobacco Cessation Clinic and VA quitline Both groups will receive pharmacotherapy
The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 24-40951 | OTHER | University Of California San Francisco | None |