Trial Outcomes & Findings for Smoking Termination Enhancement Project (STEP) (NCT NCT01065506)
NCT ID: NCT01065506
Last Updated: 2016-02-04
Results Overview
Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
End of treatment (10 weeks post quit day) and 30-week follow-up
Results posted on
2016-02-04
Participant Flow
Of the 150 enrolled participants, 7 participants completed a baseline assessment, then subsequently dropped out of the study before receiving any treatment. 7 participants were used as pilots. Accordingly, results are reported for the remaining 136 participants.
Participant milestones
| Measure |
Standard Care Plus Wellness Program
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals
|
Standard Care Plus Exercise Program
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
72
|
|
Overall Study
End of Treatment
|
44
|
37
|
|
Overall Study
4-Month Follow-Up
|
35
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
32
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Termination Enhancement Project (STEP)
Baseline characteristics by cohort
| Measure |
Standard Care Plus Wellness Program
n=64 Participants
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program
|
Standard Care Plus Exercise Program
n=72 Participants
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.39 years
STANDARD_DEVIATION 11.30 • n=5 Participants
|
43.12 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
44.19 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
72 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
ASI-3
|
18.63 units on a scale
STANDARD_DEVIATION 10.36 • n=5 Participants
|
18.04 units on a scale
STANDARD_DEVIATION 12.72 • n=7 Participants
|
18.32 units on a scale
STANDARD_DEVIATION 11.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment (10 weeks post quit day) and 30-week follow-upPopulation: Participants who completed the end of treatment assessment
Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up
Outcome measures
| Measure |
Standard Care Plus Wellness Program
n=44 Participants
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program
|
Standard Care Plus Exercise Program
n=37 Participants
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise
|
|---|---|---|
|
Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
End of treatment
|
5 number of participants
|
9 number of participants
|
|
Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
Follow-up (n=35, 34)
|
4 number of participants
|
9 number of participants
|
Adverse Events
Standard Care Plus Wellness Program
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Plus Exercise Program
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care Plus Wellness Program
n=64 participants at risk
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program
|
Standard Care Plus Exercise Program
n=72 participants at risk
Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Malignant melanoma
|
0.00%
0/64
|
1.4%
1/72 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Vertebrae fractures
|
1.6%
1/64 • Number of events 1
|
0.00%
0/72
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place