Relapse-Prevention Booklets as an Adjunct to a Tobacco Quitline: A Randomized Controlled Effectiveness Trial

Abstract

Relapse prevention (RP) remains a major challenge to smoking cessation. Previous research found that a set of self-help RP booklets significantly reduced smoking relapse. This study tested the effectiveness of RP booklets when added to the existing services of a telephone quitline.
Quitline callers (N = 3458) were enrolled after their 2-week quitline follow-up call and randomized to one of 3 interventions: (1) Usual Care (UC): standard intervention provided by the quitline, including brief counseling and nicotine replacement therapy; (2) Repeated Mailings (RM): 8 Forever Free RP booklets sent to participants over 12 months; and (3) Massed Mailings (MM): all 8 Forever Free RP booklets sent upon enrollment. Follow-ups were conducted at 6-month intervals, through 24 months. The primary outcome measure was 7-day-point-prevalence-abstinence.
Overall abstinence rates were 61.0% at baseline, and 41.9%, 42.7%, 44.0%, and 45.9% at the 6-, 12-, 18- and 24-month follow-ups, respectively. Although RM produced higher abstinence rates, the differences did not reach significance for the full sample. Post-hoc analyses of at-risk subgroups revealed that among participants with high nicotine dependence (n=1593), the addition of RM materials increased the abstinence rate at 12 months (42.2% versus 35.2%; OR=1.38; CI=1.03 -1.85; p=.031) and 24 months (45% versus 38.8%; OR=1.31; CI=1.01-1.73; p=.046).
Sending self-help RP materials to all quitline callers appears to provide little benefit to deterring relapse. However, selectively sending RP booklets to callers explicitly seeking assistance for relapse prevention and those identified as highly dependent on nicotine might still prove to be worthwhile.
© The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Full text

Nicotine & Tobacco Research, 2015, 1–8
doi:10.1093/ntr/ntv079
Original investigation
© The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.
For permissions, please e-mail: journals.permissions@oup.com.
1
Introduction
Long-term smoking cessation is related to decreased mortality and mor-
bidity,1–3 yet most smokers who achieve short-term abstinence eventu-
ally relapse to smoking. Among self-quitting smokers, the relapse rate
may be as high as 95%.4 Among smokers receiving cessation treatment,
70% relapse.5 Even among smokers who successfully abstain for one
full year, 10% eventually return to regular smoking.6 Consequently,
effective interventions aimed at relapse prevention (RP) are essential
for long-term cessation and decrease in smoking-related illness.
Cognitive behavioral counseling combined with pharmaco-
therapy is the most effective evidence-based approach to smoking
Original investigation
Relapse-Prevention Booklets as an Adjunct to
a Tobacco Quitline: ARandomized Controlled
EffectivenessTrial
MarinaUnrod PhD1,2, Vani N.Simmons PhD1,2, Steven K.Sutton PhD1, K.
MichaelCummings PhD3, PaulaCelestino BS4, Benjamin M.Craig PhD1,2,
Ji-HyunLee PhD5, Lauren R.Meltzer BA1,2, Thomas H.Brandon PhD1,2
1Department of Health Outcomes and Behavior, H.Lee Moffitt Cancer Center and Research Institute, Tampa, FL;
2Department of Psychology, University of South Florida, Tampa, FL; 3Department of Psychiatry and Behavioral
Sciences, Medical University of South Carolina, Charleston, SC; 4Department of Health Behavior Roswell Park Cancer
Institute, Buffalo, NY; 5Department of Internal Medicine University of New Mexico Cancer Center, Albuquerque, NM
Corresponding Author: Thomas H.Brandon, PhD, Tobacco Research and Intervention Program, Department of Health
Outcomes and Behavior, Moffitt Cancer Center, 4115 E.Fowler Avenue, Tampa, FL 33617, USA. Telephone: 813-745-1750;
Fax: 813-449-8247; E-mail: thomas.brandon@moffitt.org
Abstract
Introduction: Relapse prevention (RP) remains a major challenge to smoking cessation. Previous
research found that a set of self-help RP booklets significantly reduced smoking relapse. This study
tested the effectiveness of RP booklets when added to the existing services of a telephone quitline.
Methods: Quitline callers (N=3458) were enrolled after their 2-week quitline follow-up call and
randomized to one of three interventions: (1) Usual Care: standard intervention provided by the
quitline, including brief counseling and nicotine replacement therapy; (2) Repeated Mailings (RM):
eight Forever Free RP booklets sent to participants over 12months; and (3) Massed Mailings: all
eight Forever Free RP booklets sent upon enrollment. Follow-ups were conducted at 6-month inter-
vals, through 24months. The primary outcome measure was 7-day-point-prevalence-abstinence.
Results: Overall abstinence rates were 61.0% at baseline, and 41.9%, 42.7%, 44.0%, and 45.9% at the
6-, 12-, 18- and 24-month follow-ups, respectively. Although RM produced higher abstinence rates,
the differences did not reach significance for the full sample. Post-hoc analyses of at-risk subgroups
revealed that among participants with high nicotine dependence (n=1593), the addition of RM
materials increased the abstinence rate at 12months (42.2% vs. 35.2%; OR=1.38; 95% CI=1.03% to
1.85%; P=.031) and 24months (45% vs. 38.8%; OR=1.31; 95% CI=1.01% to 1.73%; P=.046).
Conclusions: Sending self-help RP materials to all quitline callers appears to provide little benefit to
deterring relapse. However, selectively sending RP booklets to callers explicitly seeking assistance
for RP and those identified as highly dependent on nicotine might still prove to be worthwhile.
Nicotine & Tobacco Research Advance Access published April 24, 2015
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Nicotine & Tobacco Research, 2015, Vol. 00, No. 002
cessation.5 Counseling interventions usually include and emphasize
RP. However, very few smokers use counseling, often citing incon-
venience.7 Therefore, the public health impact of this approach has
been limited by poor population reach. On the other hand, telephone
quitlines are effective5,8 and offer convenience as well as high cost-
effectiveness relative to most other interventions for smoking cessa-
tion.9–13 Quitlines currently exist in all US states and throughout the
world, reaching a large proportion of smokers annually.14 However,
as with other cessation interventions, the rate of smoking relapse
among quitline users remains high.15–19
A recent meta-analysis found that self-help approaches (ie, mini-
mal interventions such as written materials) were the only empiri-
cally-supported interventions for preventing smoking relapse.20 One
such self-help intervention was found to be efcacious and cost-effec-
tive among recently quit smokers.21–23 This intervention comprises a
series of booklets, called Forever Free, with content that draws on
empirical and theoretical research in RP.24–25 Aquasi-experimental
study previously found that these booklets also reduced relapse
among callers to a state tobacco quitline, but only among those
who had not received pharmacotherapy.26 Additionally, a modied
version of the booklets was found to reduce postpartum smoking
relapse among lower income women.27
The Forever Free intervention offers potential for further enhanc-
ing public health impact by adding a low-cost relapse-prevention
component to existing telephone quitlines. The goal of the current
study was to test the real-world effectiveness of adding the relapse-
prevention booklets to the services of an existing state quitline. Based
upon our previous research,21–22 we hypothesized that the Forever
Free booklets would improve the long-term abstinence rates among
adult smokers calling a telephone quitline. Although the booklets
were originally developed to be distributed over 12months,21 they
were subsequently found to be equally efcacious and more cost-
effective among self-quitters when delivered all at once.22 Hence, the
two different distribution schedules were tested in the current clini-
cal trial, with no specic hypothesis regarding their relative effective-
ness for quitline callers.
Methods
Design Overview
A randomized three-arm equal allocation design was used to test the
effectiveness of the Forever Free booklets among state quitline call-
ers. The three conditions included: (1) Usual care (UC), comprised of
the standard interventions provided by the New York State Smokers’
Quitline (NYSSQL); (2) Repeated Mailings (RM), which included
UC, plus the eight Forever Free booklets sent to participants over a
12-month period; and (3) Massed Mailings (MM), which included
UC, plus the eight Forever Free booklets sent to participants all at
once. Assessments occurred at 6-month intervals, through 24months.
Participants
Participants were clients of the NYSSQL. The inclusion criteria were
(1) smoked at least 10 cigarettes per day over the month prior to call-
ing the quitline; (2) at least 18years old; (3) able to speak and read
English; and (4) reached by the NYSSQL at their 2-week call back
(see Procedures). Because quitline callers were offered smoking ces-
sation medication, exclusion criteria included pregnancy or breast-
feeding, heart attack or stroke within the past 2 weeks, current use
of bupropion or varenicline, and serious cardiovascular problems
(unless approved by their physician). There was no racial or gender
bias in the selection of participants. Although the intervention was
initially developed for individuals who had already achieved short-
term abstinence, the intent of this effectiveness trial was to facili-
tate dissemination by minimizing burden to the quitline operators.
Therefore, tobacco abstinence was not an inclusion criterion.
Procedures
This study was approved by the Institutional Review Boards at
the University of South Florida and Roswell Park Cancer Institute.
When smokers called the NYSSQL, an initial interview included col-
lection of basic demographic information, smoking history, and eli-
gibility screening for nicotine replacement therapy (NRT). Eligible
smokers were then mailed 2 weeks of NRT. Approximately 2 weeks
(10–14 days) following initial contact, quitline specialists called
clients back to verify that they had received the NRT, provide any
additional assistance, and inform eligible clients about the oppor-
tunity to participate in the relapse-prevention clinical trial. Clients
were invited to “participate in a study to develop better ways to pro-
vide educational materials about quitting smoking.” Approximately
50%–70% of eligible NYSSQL clients were randomly selected and
invited into the study per month until the required sample size was
reached. Participants were recruited between October 2009 and
April2010.
Upon providing verbal approval, participants were randomized
(without stratication or blocking) to 1 of 3 treatment conditions
and contact information was acquired. Random allocation sequence
was generated by NYSSQL research team using a pseudo-random
number generator algorithm using a seed value of number of sec-
onds from midnight at the time of the call. The quitline specialists
inviting clients to participate in the study were not aware of the
treatment assignment. All assessments (baseline and follow-up) and
intervention materials were sent to participants via US mail. The
treatment implementation and research roles were separated by site:
the NYSSQL team sent all intervention materials at appropriate time
points, and the Moftt Cancer Center research team sent and received
all of the assessment questionnaires. Receipt of the completed base-
line questionnaire constituted consent for participation and enroll-
ment into the study. Follow-up assessments were conducted via mail
at 6-month intervals through 24months. Participants were paid $20
for completing each assessment questionnaire, with a bonus pay-
ment of $50 if they completed all ve assessments.
Intervention Conditions
Usual Care Condition
This condition comprised the standard intervention provided to cur-
rent smokers who called the NYSSQL. It included the initial contact
call and coaching interview, provision of a 2-week starter kit of NRT
(client had a choice of nicotine transdermal patch, nicotine gum, or
nicotine lozenge), and a 2-week proactive follow-up coaching tel-
ephone call. A“Ready to Quit” kit was mailed to current smokers
after the initial call and included a congratulatory cover letter, a “Break
Loose” stop smoking guide, a medications chart, and two single-page
fact sheets about dealing with nicotine withdrawal and maintaining
abstinence.
Repeated Mailing Condition
This condition comprised UC, plus eight Forever Free relapse-
prevention booklets delivered as originally developed.21 The rst
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Nicotine & Tobacco Research, 2015, Vol. 00, No. 00 3
booklet was mailed after participants were enrolled into the study,
and the rest were mailed at the following time points: 1, 2, 3, 5, 7, 9,
and 12months. The rst booklet, “An Overview,” provides a general
overview about quitting smoking, and each of the remaining seven
booklets include more extensive information on topics related to
maintaining abstinence: Smoking Urges; Smoking and Weight; What
if You Have a Cigarette?; Your Health; Smoking, Stress, and Mood;
Lifestyle Balance; and Life without Cigarettes. The content of the
booklets is based on cognitive-behavioral theory24,28 and draws upon
principles that typically represent the key relapse-prevention coun-
seling interactions that occur in the clinical setting. They are written
at the fth to sixth grade reading level to maximize their accessibility
to a wide range of individuals.29 The printing cost of the eight book-
lets was $5.58 per person.
Massed Mailing Condition
This condition comprised UC, plus the identical eight booklets as in
the RM condition, but all of the booklets were sent to participants in
a bundle upon study enrollment.
Measures
Baseline Measures
Demographic and smoking-related characteristics were assessed. The
Fagerström Test for Nicotine Dependence,30 a standard, validated
6-item questionnaire, assessed tobacco dependence. Motivation to
stop smoking was assessed via the Contemplation Ladder31 and the
Stages of Change algorithm.32 The Abstinence-Related Motivational
Engagement scale,33 a 16-item questionnaire, was used to measure
post-cessation commitment to remaining smoke-free as evidenced
by level of involvement in the quitting and maintenance process.
Participant evaluation of the quitline services was assessed using the
Client Satisfaction Questionnaire (CSQ).34 The items were rated on a
scale of 1–4, with a total score range of 7–28. Ave-point item was
used to measure condence in being smoke-free in 6months. Finally,
current and past use of smoking cessation interventions and cessa-
tion aids were assessed.
Follow-up Measures
At each follow-up, tobacco, and any use of pharmacotherapy or
other smoking cessation assistance since the previous contact were
assessed. Motivation to quit smoking, including the Contemplation
Ladder, the Stages of Change algorithm, the Abstinence-Related
Motivational Engagement, the CSQ, and the one-item measure of
condence to be smoke-free in 6months were assessed. Eight CSQ-
based items assessed participants’ evaluation of the Forever Free
booklets. The CSQ items were rated on a scale of 1–4, with a total
score range of 8–32. Participants in the two Forever Free treatment
conditions reported at 12, 18, and 24months which of the eight
booklets they received. The primary outcome measure was 7-day
point-prevalence abstinence.
SampleSize
Sample size was selected to detect minimum differences of 5% in the
primary outcome measure (abstinence rates between pairs of condi-
tions) using generalized estimating equation analyses. Apriori sample
size calculation indicated that at least 1133 smokers per condition
would provide 80% power to detect differences under conservative
assumptions about both the possible range of abstinence rates of UC
condition and rates of attrition over the course of the study.
Statistical Analyses
Data analyses occurred in 2013–2014. Baseline demographic and
smoking characteristics were compared across treatment conditions
using one-way analyses of variance and chi-square tests, depending
on the characteristics of the variable being tested. Satisfaction with
quitline services at baseline and satisfaction with treatment at 6- and
12-month follow-ups was compared across the treatment condi-
tions using analyses of variance. The primary hypotheses (Forever
Free conditions vs. UC) were assessed using generalized estimating
equations with an autoregressive working correlation structure. In
the base model, treatment, time, and their interaction were used to
predict 7-day point-prevalence across the four follow-ups. Potential
moderators were tested individually by adding the moderator and
associated interaction terms to the basemodel.
We used multiple imputation to handle missing data, which
occurred primarily because of follow-up surveys not being returned
at each of the four follow-up time-points (Figure1). Our imputa-
tion approach used a Markov Chain Monte Carlo method35 which is
based upon a missing at random assumption. Twenty imputed data
sets were generated via PROC MI procedure in SAS software (SAS,
version 9.3). The procedure incorporated 16 variables and 12 inter-
action terms: (1) smoking status at baseline and the four follow-ups,
(2) the predictors for the models being tested (ie, treatment condition
plus seven demographic and four smoking-related variables to be
assessed as moderators), and (3) 12 computed variables representing
the interaction of a moderator variable with treatment. Binary smok-
ing status at each follow-up was nalized using adaptive rounding.36
Results
Recruitment and Baseline Demographics
The CONSORT ow diagram is presented in Figure1. Of the 7589
NYSQL clients invited to participate in the study, 5752 (76%) pro-
vided preliminary verbal consent and were randomized to treatment
conditions. Of those randomized, 3458 (60%) returned the base-
line questionnaire indicating consent and were enrolled in the study.
Follow-up return rates did not differ statistically between groups.
Participant characteristics at baseline are presented in Table 1.
Comparisons of the UC group with each of the two Forever Free
groups revealed two signicant differences. There was a higher per-
centage of males in the RM group (56.6%) compared to UC group
(51.7%), X2(1)=5.50, P=.019. In addition, participants in the MM
group reported a higher average cigarettes per day (20.3) compared to
those in the UC group (19.2), t(2306)=2.95, P=.009. Controlling for
these differences did not affect the primary cessation outcome results.
Survey ReturnRates
Follow-up survey return rates decreased over time (Figure1): 51.9%
returned all four follow-ups, with no group differences, and 15.6%
returned none of the follow-ups, with a lower percentage of those
in the UC group (13.0%) than in the MM (16.0%) and the RM
(17.8%) groups (Ps < .05). Compared to those who returned at least
one follow-up survey, participants who did not return any follow-up
surveys were more likely to be abstinent at baseline, female, a racial
and/or ethnic minority, married, uninsured, and younger (Ps < .01).
Treatment Satisfaction
On average, participants were highly satised with the services they
received from the NYSSQL. The overall mean score on the CSQ at
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Nicotine & Tobacco Research, 2015, Vol. 00, No. 004
baseline was 25.47 (SD=2.85). There were no differences between
the three treatment groups on satisfaction with NYSSQL services.
Similarly, participants in the two Forever Free treatment conditions
reported high levels of satisfaction with the intervention booklets.
The overall mean score on the CSQ at the 6-month follow-up was
25.76 (SD=4.61). At 12months, the time by which the RM group
participants have received all of the intervention booklets, the over-
all mean score on the CSQ was 26.09 (SD= 4.69). There were no
differences between the MM and RM groups on satisfaction with
the Forever Free intervention materials at either time-point.
Cessation Outcomes
Table2 presents abstinence rates for each condition at each time
point. The 7-day point-prevalence abstinence rate for the entire sam-
ple at baseline was 61%. The overall abstinence rates were 41.9%,
42.7%, 44%, and 45.9% at the 6-, 12-, 18-, and 24-month follow-
ups, respectively. The RM intervention consistently produced some-
what higher abstinence rates than the UC and MM interventions.
However, generalized estimating equation analyses comparing either
MM or RM against UC did not nd signicant group differences
or group × time interactions. Analyses of smoking status at follow-
up among the subset of participants (n= 2108) who had achieved
abstinence by the baseline assessment (the true target of RP) also
failed to reveal signicant group differences in outcomes, with simi-
lar patterns of abstinence rates across conditions, but higher rates of
abstinence overall. For example, at 24months, the abstinence rates
were 57.2%, 55.5%, and 61.7% for the UC, MM, and RM condi-
tions, respectively.
None of the demographic or smoking-related variables presented
in Table 1 were found to be signicant moderators of the treat-
ment effect. Post-hoc analyses were performed to compare the RM
and UC participants based on “at-risk” subgroups, including low
income, low education, racial and/or ethnic minority, and nicotine
dependence. For each of the “at-risk” groups, the demographic and
smoking-related variables were assessed and no signicant group
differences emerged. Therefore, analyses of treatment effects were
conducted without any covariates. Logistic regression was used to
assess abstinence rates at the 12-month follow-up (corresponding
to the end of treatment in the RM condition), and the 24-month
follow-up (corresponding to 12 month post treatment in the RM
condition). As can be seen in Table3, for those with relatively high
nicotine dependence (Fagerström Test for Nicotine Dependence > 5;
n= 1593), the RM condition showed higher abstinence rates than
the UC condition at two critical time points. At 12months, the absti-
nence rates were 42.2% versus 35.2% (OR=1.38, 95% CI=1.03%
to 1.85%, P=.031). At 24months, the abstinence rates were 45.0%
versus 38.8% (OR=1.31, 95% CI=1.01% to 1.73%, P=.046).
Lastly, in an effort to evaluate treatment integrity, participants in
both of the Forever Free treatment groups were asked whether they
received and read the intervention materials. With regard to receipt
of intervention, among responders at the 12-, 18-, and 24-month
follow-ups, 12.5% of the MM group and 8.0% of the RM group
did not endorse receipt of a single booklet. Those who reportedly did
Invited to Participate
n = 7589
Forever Free
Massed Mailing
n= 1127
Completed Follow-ups
6 month: n= 827 (73%)
12 month: n= 787 (70%)
18 month: n= 733 (65%)
24 month: n= 735 (65%)
Forever Free
Repeated Mailing
n= 1142
Completed Follow-ups
6 month: n= 814 (71%)
12 month: n= 802 (70%)
18 month: n = 715 (63%)
24 month: n= 735 (64%)
Usual Care
n = 1189
Completed Follow-ups
6 month: n= 906 (76%)
12 month: n= 874 (74%)
18 month: n= 798 (67%)
24 month: n= 798 (67%)
Agreed to Participate and Randomized
n= 5752 (76%)
Declined
n= 1881
Enrolled
n= 3458 (60%)
Excluded (failed to return baseline
or returned late)
n= 2294
Analysed
n= 1189
Analysed
n= 1127
Analysed
n = 1142
Figure1. CONSORT flow diagram.
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Nicotine & Tobacco Research, 2015, Vol. 00, No. 00 5
not receive the intervention tended to have lower abstinence rates
by 6.6%–8.1% across follow-up points than those who reported
receiving the booklets, although the differences did not reach signi-
cance (Ps=.071–.161). With regard to whether participants read the
booklets, 90% of responders reported having read the intervention
booklets. At the 6- and 12-month follow-ups, abstinence rates were
42.8% and 43.70%, respectively, among those who reportedly read
the booklets, compared with 27% and 29% among those who did
not read the booklets (Ps < .03). The differences between those who
read and those who did not read the booklets dropped to approxi-
mately 5% at the 18- and 24-month follow-ups, and were no longer
signicant (Ps > .28). Finally, we compared smoking status for the
participants in the RM group who reported having read the booklets
to those in the UC group. Similar to the primary outcomes, absti-
nence rates were greater for the RM group, but the difference did not
reach signicance at any of the follow-ups (all Ps > .17).
Discussion
This randomized controlled trial tested the real-world effectiveness
of adding eight self-help relapse-prevention booklets to the stand-
ard services provided to smokers calling a state telephone quitline.
We found that the Forever Free booklets failed to produce signi-
cantly higher abstinence rates than usual care at any follow-up point
Table1. Demographic and Smoking Variables at Baseline by Intervention Condition
Usual care (n=1189) Massed mailing (n=1127) Repeated mailing (n=1142)
Demographic variables
Sex (%): male 51.7* 54.3 56.6*
Age: M (SD) 44.0 (13.5) 43.8 (13.9) 44.0 (13.4)
Race (%):white/Caucasian 79.4 78.4 79.4
Black/African American 10.6 10.2 10.1
Other 7.9 9.4 8.1
Refused to answer 2.0 2.2 2.3
Hispanic ethnicity (%) 7.1 8.9 9.7
Education (%):less than HS diploma 8.7 12.3 11.1
HS diploma or GED 35.9 35.4 35.3
College or technical school 54.2 50.3 52.7
Refused to answer 1.0 1.0 1.0
Insured (%) 74.6 76.3 74.5
Married/living together (%) 42.6 43.2 40.9
Household income (median category) $20–$30 000 $20–$30 000 $20–$30 000
Smoking-related variables
Cigarettes per day: M (SD) 19.2 (8.8)** 20.3 (9.3)** 19.8 (8.9)
FTND: M (SD) 5.1 (2.2) 5.2 (2.3) 5.2 (2.2)
Years smoked: M (SD) 22.3 (12.9) 22.9 (13.1) 22.5 (12.4)
Previous quit attempt: % 39.6 37.7 38.2
Live with smoker(s): % 36.9 38.7 37.5
Contemplation Ladder (0–11): M (SD) 9.9 (1.7) 9.8 (1.8) 9.8 (1.8)
SOC—action: % 54.2 53.1 54.6
FTND=Fagerström Test for Nicotine Dependence; GED=general equivalency diploma; HS=high school; SOC=Stages of Change.
*P < .05; **P < .01 between treatment groups.
Table2. Abstinence Rates (%) at Baseline and Follow-ups by Intervention Condition
Usual care (n=1189) Massed mailing (n=1127) Repeated mailing (n=1142) Full sample (N=3458)
Baseline 60.6 60.7 61.6 61.0
6months 41.3 40.2 44.1 41.9
12months 41.9 41.2 45.1 42.7
18months 43.9 43.0 45.1 44.0
24months 45.4 44.3 48.0 45.9
No statistically signicant group differences or interactions were found; results based on multiple imputation (20 data sets).
Table3. Abstinence Rates (%) at Baseline and Follow-ups by Intervention for Smokers With High Nicotine Dependence
Usual care (n=528) Massed mailing (n=536) Repeated mailing (n=529) All (n=1593)
Baseline 56.4 57.9 59.7 58.0
6months 36.4 38.5 42.0 39.0
12months 35.2* 37.3 42.2* 38.2
18months 37.0 40.4 43.1 40.2
24months 38.8* 41.3 45.0* 41.7
*P < .05 between intervention groups; results based on multiple imputation (20 data sets).
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Nicotine & Tobacco Research, 2015, Vol. 00, No. 006
over 24months. However, post-hoc analyses revealed that among
individuals who reported high nicotine dependence at baseline, the
provision of the Forever Free booklets distributed over a 12-month
period produced higher quit rates relative to the standard quitline
services at 12 and 24months. Booklets delivered all at once did not
produce higher abstinence rates than usual care. This contrasts with
an earlier study of self-quitters, which found equivalent outcomes
for the two distribution schedules.22 It may be that the booklets pro-
vide little additional benet when they follow so closely in time a
multicomponent quitline intervention, whereas a longer distribution
schedule offers high-risk participants the benets of both reminders
of important concepts as well as maintained contact overtime.
The ndings from this study are in contrast to two earlier ran-
domized controlled trials that did observe a benet of providing
the Forever Free booklets to smokers.21–22 However, both these ear-
lier trials were based on unassisted recent quitters who proactively
sought assistance for relapse-prevention. By contrast, the partici-
pants in the current study were smokers seeking assistance to stop
smoking who were provided the Forever Free booklets as an adjunct
to the Quitline service, which already included the provision of free
NRT and counseling support. The conicting ndings between stud-
ies suggests the possibility that the Forever Free booklets, may be
useful to subgroups of smokers who might contact a Quitline, such
as those explicitly seeking assistance for RP, and perhaps heavily
addicted smokers. However, it appears that sending self-help relapse-
prevention materials to all Quitline callers adds little benet to deter-
ring relapse, and is therefore not recommended. This interpretation
is consistent with a previous nding in which the Forever Free book-
lets reduced relapse only among quitline callers who did not receive
pharmacotherapy.26 In the current study, all quitline callers received
NRT, and hence, it was not possible to test or replicate the previous
nding with non-NRTusers.
When added to existing interventions, minimal self-help inter-
ventions, particularly those delivered across an extended time-frame,
may have their greatest impact upon subgroups of smokers at greater
risk, such as those with high nicotine dependence or those receiving
substandard treatment (ie, self-quitters or quitline callers who do not
receive NRT). This conclusion is also consistent with a recent nding
that a similar self-help intervention for pregnant women was effec-
tive only for those in low-income households, perhaps due to lower
access to services, resources, and optimal treatments.27 It is impor-
tant to note, however, that the current intervention effect among
highly dependent smokers was a post-hoc nding for which chance
cannot be ruled out. Future effectiveness research is needed to repli-
cate the booklets’ impact among highly nicotine dependent smokers.
Another reason for lack of a treatment effect may be the high
abstinence rate (45.4%) achieved by the UC condition. To date, the
best telephone quitline outcomes in the literature have been found
with multiple counseling calls, with reported abstinence rates of
up to 27%,18,37,38 although one study found little benet beyond
two counseling calls.15 The high 24-month abstinence rate in the
UC condition may reect selection bias. That is, participants who
were available for the 2-week quitline call, agreed to participate in
the study, and returned their baseline questionnaire may have had
greater motivation to quit smoking. Another possibility is that,
although each assessment was relatively brief by design, the regu-
larly scheduled multiple assessments may have enhanced the percep-
tion of social support, which has been found to improve cessation
outcomes.39 The multiple assessments may have also produced a
“Hawthorne” or trial effect,40 resulting in higher than expected quit
rates. The multiple contacts combined with provision of NRT and
brief telephone counseling may have left little room for additional
improvement by a minimal self-help intervention.
In an effort to explore another potential reason for the lack of
outcome differences, we evaluated treatment integrity and found
that between 8%–12% of participants claimed to have not received
the Forever Free booklets. Although this nding did not impact the
overall treatment outcomes, it highlights the inherent challenges
that may be encountered in real-world effectiveness studies in which
the researchers do not have direct control of intervention delivery.
On the other hand, 90% of participants who reported receiving the
booklets said that they read them. The high treatment compliance is
consistent with high levels of satisfaction with the Forever Free inter-
vention reported by participants in the current study. However, simi-
lar to results regarding receipt of booklets, having read the booklets
did not impact the overall treatment outcomes.
This study has several strengths. It represents a real-world effec-
tiveness trial evaluating a self-help intervention delivered to quitline
clients via mail. The intervention draws on empirical and theoretical
research in RP. The study methodology allowed for evaluation of
24months of outcomes. Finally, the large, diverse sample provided
the statistical power to test both main effects, as well as moderating
variables.
The primary limitation of this study is related to generalizability.
There is considerable variability in the amount and type of services
provided by telephone quitlines in the United States and Canada.41
Services may include self-help materials, one or more proactive tel-
ephone counseling sessions, various types and amounts of cessa-
tion pharmacotherapy, or various combination of the above. The
NYSSQL offered at least two proactive telephone counseling ses-
sions, NRT, and educational materials consisting of a cessation guide
and information about nicotine withdrawal. The Forever Free book-
lets may be more effective among quitlines with fewer resources or
without pharmacotherapy, as suggested by prior research.26 Given
the low cost of the Forever Free booklets, testing this intervention
with telephone quitlines that have limited resources and provide
low-intensity services may still be warranted. An additional general-
izability-related factor is that the study sample consisted of predomi-
nantly Caucasian smokers who had some college or technical school
education. However, given that there were no outcome differences
by racial/ethnic minority status or by level of education, results from
this study are likely to generalize to populations consisting of vari-
able race, ethnicity, and education demographics.
Another limitation is the lack of biochemical verication of
cessation status due to logistical barriers. However, this decision
is consistent with research showing that there is little benet from
inclusion of biochemical verication in low-intensity interventions
without strong incentives to report false abstinence.42
In summary, the ndings from this study suggest that sending
self-help relapse-prevention booklets to all Quitline callers adds lit-
tle benet to deterring relapse, and is therefore not recommended.
However, selectively sending RP materials to callers explicitly seek-
ing assistance for RP, and those identied as highly dependent on
nicotine, may prove to be worthwhile.
Funding
This work was supported by National Cancer Institute of the National
Institutes of Health under award number R01CA137357. This work has also
been supported in part by the Biostatistics and Survey Methods Core Facilities
at Society for Research on Nicotine and Tobacco member access on April 29, 2015http://ntr.oxfordjournals.org/Downloaded from

Nicotine & Tobacco Research, 2015, Vol. 00, No. 00 7
at the H. Lee Moftt Cancer Center and Research Institute, an NCI desig-
nated Comprehensive Cancer Center (P30CA76292). The content is solely the
responsibility of the authors and does not necessarily represent the ofcial
views of the National Institutes of Health.
Declaration of Interests
THB has received research support from Pzer, Inc. KMC has received grant
funding from the Pzer Corporation to study the impact of a hospital based
tobacco cessation intervention. He also receives funding as an expert witness
in litigation led against the tobacco industry. No other nancial disclosures or
conicts of interest were reported by the authors of this paper.
Acknowledgments
The authors would like to thank the study staff, Krissie Sismilich and Monica
Carrington, for their assistance with implementing this study.
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