Smoking Cessation
Conditions
Keywords
Smoking Cassation, Immigrants, Economic Disparity
Brief summary
This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.
Detailed description
This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.
Interventions
BEHAVIORALIntegrated Smoking Cessation and Financial Counseling
Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
BEHAVIORALWaitlist Integrated Smoking Cessation and Financial Counseling
Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
DRUGNicotine Replacement Therapy (NRT)
Participants in both arms will be eligible to receive a free four-week supply of NRT.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smokes ≥5 cigarettes per day * Born outside the U.S. * Interested in receiving smoking and financial counseling * Self-reported income below 200% of the current federal poverty level for a given household composition * New York City resident * English or Spanish language * Able to provide informed consent, and * Does not have a representative who manages his/her funds (to ensure the participant has the ability to manage household money). We will exclude participants who report being pregnant or breastfeeding (unable to receive NRT). Hospital staff participants: * Must be current medical or non-medical provider or administrator at Bellevue Hospital or New York University Lutheran Medical Center
Exclusion criteria
* We will exclude participants who report being pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) | 6 Months | Participants answered In the past 7 days, have you smoked a cigarette? (yes/no); % of yes is reported per arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Integrated Smoking Cessation and Financial Counseling: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT. | 208 |
| Waitlist Control Waitlist Integrated Smoking Cessation and Financial Counseling: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
Nicotine Replacement Therapy (NRT): Participants in both arms will be eligible to receive a free four-week supply of NRT. | 202 |
| Total | 410 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Waitlist Control |
|---|---|---|---|
| Age, Continuous | 53.2 years | 52.85 years | 52.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 105 Participants | 222 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 188 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 98 Participants | 190 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 23 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 51 Participants | 94 Participants | 43 Participants |
| Race (NIH/OMB) White | 42 Participants | 81 Participants | 39 Participants |
| Region of Enrollment United States | 208 participants | 410 participants | 202 participants |
| Sex: Female, Male Female | 69 Participants | 146 Participants | 77 Participants |
| Sex: Female, Male Male | 139 Participants | 264 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 208 | 1 / 202 |
| other Total, other adverse events | 0 / 208 | 0 / 202 |
| serious Total, serious adverse events | 11 / 208 | 5 / 202 |
Outcome results
Primary
% of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline)
Participants answered In the past 7 days, have you smoked a cigarette? (yes/no); % of yes is reported per arm
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Arm | % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) | 27 % of participants |
| Waitlist Control | % of Participants Who Had Smoked Cigarette(s) in the Past 7 Days (at 6 Months From Baseline) | 13 % of participants |