Trial Outcomes & Findings for Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers (NCT NCT02596711)
NCT ID: NCT02596711
Last Updated: 2020-03-10
Results Overview
The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Averaged across 3 study visits (Week 0 to Week 12)
Results posted on
2020-03-10
Participant Flow
Participants were recruited from the Houston metropolitan area (Harris County, Texas) through fliers at community centers and local health clinics as well as through advertisements online and in print newspapers between February of 2016 and January of 2017.
During baseline visit (prior to randomization), an expired carbon monoxide sample was collected using Bedfont Micro+Smokerlyzer.Additionally, participants able to become pregnant were required to take a routine hCG urine sample pregnancy test to rule out potential pregnancy.An assessment battery was also administered at the baseline visit.
Participant milestones
| Measure |
Health Education (HE)
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
|
Overall Study
Visit 2
|
9
|
7
|
6
|
|
Overall Study
Visit 3
|
7
|
8
|
6
|
|
Overall Study
3 Month Follow-up
|
8
|
6
|
6
|
|
Overall Study
6 Month Follow-up
|
8
|
6
|
5
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Health Education (HE)
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
Baseline Characteristics
Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
Baseline characteristics by cohort
| Measure |
Health Education (HE)
n=9 Participants
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 11 • n=5 Participants
|
46 years
STANDARD_DEVIATION 10.94 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 13.92 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 11.53 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Averaged across 3 study visits (Week 0 to Week 12)The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Outcome measures
| Measure |
Health Education (HE)
n=9 Participants
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Intervention Feasibility & Acceptability
|
4.87 score on a scale
Standard Deviation 0.35
|
4.71 score on a scale
Standard Deviation 0.48
|
4.83 score on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
Outcome measures
| Measure |
Health Education (HE)
n=9 Participants
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Patch Adherence: Percentage of Days With Patch
|
64.6 percentage of NRT patch days
Standard Deviation 17.7
|
68.6 percentage of NRT patch days
Standard Deviation 13.66
|
81.3 percentage of NRT patch days
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: Collected at the 3- and 6-month follow-up visitsRates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.
Outcome measures
| Measure |
Health Education (HE)
n=9 Participants
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
n=8 Participants
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Number of Abstinent Participants
3-month follow-up
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Abstinent Participants
6-month follow-up
|
4 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Health Education (HE)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Culturally-Tailored (CT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Culturally-Tailored With Adherence Enhancement (CT+AE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Health Education (HE)
n=9 participants at risk
Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored (CT)
n=8 participants at risk
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
Culturally-Tailored With Adherence Enhancement (CT+AE)
n=8 participants at risk
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea and changes in appetite, likely related to increase in patch dosage
|
11.1%
1/9 • Number of events 1 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
|
General disorders
Rapid heart rate and anxiety, likely related to patch use
|
11.1%
1/9 • Number of events 1 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
|
Psychiatric disorders
Sleep disturbances, anxiety, abnormal taste in mouth, trouble concentrating, sad mood.
|
0.00%
0/9 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
12.5%
1/8 • Number of events 1 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
|
Psychiatric disorders
Mild sleep disturbance and irratbility.
|
11.1%
1/9 • Number of events 1 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
|
General disorders
Sleep disturbance, constipation, skin irritation and lesion at patch site, lower back pain, phlegm i
|
0.00%
0/9 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
12.5%
1/8 • Number of events 1 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
0.00%
0/8 • End of treatment and 6 month follow-up
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.
|
Additional Information
Dr. Marcel A. de Dios / Health Disparities Research
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place