Trial Outcomes & Findings for Nonsmokers Helping Smokers Quit (NCT NCT02010697)
NCT ID: NCT02010697
Last Updated: 2020-02-13
Results Overview
Assessment interview is conducted over the phone at 7-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3125 participants
Primary outcome timeframe
7-months post enrollment
Results posted on
2020-02-13
Participant Flow
Participant milestones
| Measure |
Messages Targeting Nonsmokers
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
one time mailing with a self-help quit kit
|
|---|---|---|---|
|
Overall Study
STARTED
|
1044
|
1038
|
1043
|
|
Overall Study
COMPLETED
|
1044
|
1038
|
1043
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nonsmokers Helping Smokers Quit
Baseline characteristics by cohort
| Measure |
Messages Targeting Nonsmokers
n=1044 Participants
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
n=1038 Participants
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
n=1043 Participants
one time mailing with a self-help quit kit
|
Total
n=3125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24
|
116 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
|
Age, Customized
25-44
|
487 Participants
n=5 Participants
|
479 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
1462 Participants
n=4 Participants
|
|
Age, Customized
45-64
|
409 Participants
n=5 Participants
|
420 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
1237 Participants
n=4 Participants
|
|
Age, Customized
65+
|
32 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
566 Participants
n=5 Participants
|
590 Participants
n=7 Participants
|
566 Participants
n=5 Participants
|
1722 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
478 Participants
n=5 Participants
|
448 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
1403 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
491 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
1514 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
289 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
874 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
121 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
AIAN
|
61 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi
|
73 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Education
0 to 8
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Education
9 to 12
|
231 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
661 Participants
n=4 Participants
|
|
Education
HSD/GED
|
343 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
1016 Participants
n=4 Participants
|
|
Education
Some College
|
372 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
1144 Participants
n=4 Participants
|
|
Education
BS+
|
58 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7-months post enrollmentAssessment interview is conducted over the phone at 7-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).
Outcome measures
| Measure |
Messages Targeting Nonsmokers
n=1044 Participants
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
n=1038 Participants
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
n=1043 Participants
one time mailing with a self-help quit kit
|
|---|---|---|---|
|
Number of Participants Reporting 30-day Abstinence
|
203 Participants
|
222 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: At intakeThe number of participants who felt they had "a lot" of support for quitting or staying quit.
Outcome measures
| Measure |
Messages Targeting Nonsmokers
n=1044 Participants
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
n=1038 Participants
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
n=1043 Participants
one time mailing with a self-help quit kit
|
|---|---|---|---|
|
Support for Quitting
|
690 Participants
|
712 Participants
|
704 Participants
|
SECONDARY outcome
Timeframe: 3-months post enrollmentAssessment interview is conducted over the phone at 3-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).
Outcome measures
| Measure |
Messages Targeting Nonsmokers
n=1044 Participants
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
n=1038 Participants
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
n=1043 Participants
one time mailing with a self-help quit kit
|
|---|---|---|---|
|
Number of Participants Reporting 30-day Abstinence
|
120 Participants
|
137 Participants
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-months post enrollmentDid participants receive counseling
Outcome measures
| Measure |
Messages Targeting Nonsmokers
n=1044 Participants
Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting nonsmokers
|
Messages Targeting Smokers
n=1038 Participants
Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.
Messages targeting smokers
|
Usual Care
n=1043 Participants
one time mailing with a self-help quit kit
|
|---|---|---|---|
|
Counseling
|
20 Participants
|
58 Participants
|
0 Participants
|
Adverse Events
Messages Targeting Nonsmokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Messages Targeting Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place