Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, smoking behavior, culturally tailored tobacco cessation intervention
Brief summary
Pilot randomized controlled trial to compare tobacco cessation rates of two arms: a 6-week culturally tailored tobacco cessation intervention versus a 6-week personalized culturally-tailored tobacco cessation intervention among African American women.
Interventions
BEHAVIORALCulturally-tailored Tobacco Treatment
Weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences.
BEHAVIORALCulturally-tailored Content Newsletters
Weekly newsletters covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics.
BEHAVIORALControl Preference Scale
Survey to elicit preference on the decision-making interaction with healthcare provider. The survey uses a 5 point scale from 1 to 5 with 1 or 2 points representing Active Control Preference; 3 or 4 representing a Collaborative Control Preference and 5 representing a Passive Control Preference.
BEHAVIORALActive Content Newsletter or Passive Content Newsletter
Based on the answers to the Control Preference Scale, participants will receive the appropriate weekly newsletter (active content or passive content). Newsletters are covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics presented in a more passive or active manner.
Sponsors
Hackensack Meridian Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Self-identify as an African American woman * Currently smoke 5 cigarettes per day or more * Has smoked daily for the past one year * Able to provide informed consent * Generally good health as determined by medical history
Exclusion criteria
* Currently pregnant * Diagnosis of cardiovascular disease * Diagnosis of lung disease * Diagnosis of mental illness * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the 6-week Tobacco Treatment Intervention | Post intervention completion - At 6 weeks | Examine the feasibility of a 6-week community-based culturally tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women by assessing the number of participants that complete all 6-week tobacco treatment calls. |
| Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention | Post intervention completion - At 6 weeks | Examine the acceptability and satisfaction of a 6-week community-based culturally-tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women using the 17-item Acceptability & Satisfaction Questionnaire. Accessibility and Satisfaction and measured using a score that ranges from 17 to 68 with higher scores representing higher Accessibility and Satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the Intervention (Fagerstrom Test) | Post intervention completion - At 6 weeks | Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using the Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a psychometrically-validated self-report 6-item tool to measure an individuals' level of nicotine dependence with a total scale score ranging from 0-10 with higher scores indicative of higher levels of nicotine dependence. |
| Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings) | 6 weeks post intervention | Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using expired air carbon monoxide readings. Higher carbon monoxide readings are associated with worse outcomes. |
| Effectiveness of Intervention | 6 weeks post intervention | Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using Stage of Change for Tobacco Cessation. The Stage of Change for Tobacco Cessation measures participants intention to quit smoking and has 4 categories: No Plans to Quit / Within the Next 6 Months/ Within the Next 30 Days / Quit. Results were compared to baseline Stage of Change. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Culturally-tailored Tobacco Treatment Intervention Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will also receive weekly Culturally-tailored Content Newsletters emailed after their weekly cessation counseling session. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Culturally-tailored Tobacco Treatment Intervention |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention
Examine the acceptability and satisfaction of a 6-week community-based culturally-tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women using the 17-item Acceptability & Satisfaction Questionnaire. Accessibility and Satisfaction and measured using a score that ranges from 17 to 68 with higher scores representing higher Accessibility and Satisfaction.
Time frame: Post intervention completion - At 6 weeks
Population: Participants who completed the intervention and the Accessibility and Satisfaction questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally-tailored Tobacco Treatment Intervention | Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention | 56.08 score on a scale | Standard Deviation 5.14 |
Primary
Feasibility of the 6-week Tobacco Treatment Intervention
Examine the feasibility of a 6-week community-based culturally tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women by assessing the number of participants that complete all 6-week tobacco treatment calls.
Time frame: Post intervention completion - At 6 weeks
Population: Participants who consented and initiated intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Culturally-tailored Tobacco Treatment Intervention | Feasibility of the 6-week Tobacco Treatment Intervention | 14 Participants |
Secondary
Effectiveness of Intervention
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using Stage of Change for Tobacco Cessation. The Stage of Change for Tobacco Cessation measures participants intention to quit smoking and has 4 categories: No Plans to Quit / Within the Next 6 Months/ Within the Next 30 Days / Quit. Results were compared to baseline Stage of Change.
Time frame: 6 weeks post intervention
Population: Baseline and post intervention Stage of Change
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of Intervention | No Plans to Quit | 0 Participants |
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of Intervention | Within the Next 6 Months | 5 Participants |
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of Intervention | Within the Next 30 Days | 9 Participants |
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of Intervention | Quit | 0 Participants |
| Culturally-tailored Tobacco Treatment Intervention - Post Intervention | Effectiveness of Intervention | Within the Next 30 Days | 6 Participants |
| Culturally-tailored Tobacco Treatment Intervention - Post Intervention | Effectiveness of Intervention | No Plans to Quit | 0 Participants |
| Culturally-tailored Tobacco Treatment Intervention - Post Intervention | Effectiveness of Intervention | Quit | 3 Participants |
| Culturally-tailored Tobacco Treatment Intervention - Post Intervention | Effectiveness of Intervention | Within the Next 6 Months | 5 Participants |
Secondary
Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using expired air carbon monoxide readings. Higher carbon monoxide readings are associated with worse outcomes.
Time frame: 6 weeks post intervention
Population: Participants who completed the air carbon monoxide readings after completing the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings) | 7.125 ppm | Standard Deviation 3.72 |
Secondary
Effectiveness of the Intervention (Fagerstrom Test)
Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using the Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a psychometrically-validated self-report 6-item tool to measure an individuals' level of nicotine dependence with a total scale score ranging from 0-10 with higher scores indicative of higher levels of nicotine dependence.
Time frame: Post intervention completion - At 6 weeks
Population: Participants who completed the Fagerström Test for Nicotine Dependence after completing the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally-tailored Tobacco Treatment Intervention | Effectiveness of the Intervention (Fagerstrom Test) | 2.5 score on a scale | Standard Deviation 2.07 |