Abstract
BACKGROUND:
Abstaining from smoking after a cancer diagnosis is critical to mitigating the risk of multiple adverse health outcomes. Although many patients with cancer attempt to quit smoking, the majority relapse. The current randomized controlled trial evaluated the efficacy of adapting an evidence-based smoking relapse prevention (SRP) intervention for patients with cancer.
METHODS:
The trial enrolled 412 patients newly diagnosed with cancer who had recently quit smoking. Participants were randomized to usual care (UC) or SRP. Participants in the UC group received the institution’s standard of care for treating tobacco use. Participants in the SRP group in addition received a targeted educational DVD plus a validated self-help intervention for preventing smoking relapse. The primary outcome was smoking abstinence at 2 months, 6 months, and 12 months.
RESULTS:
Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20). At 12 months, abstinence rates among survivors were 68% for those in the SRP group and 63% for those in the UC group (P = .38). Post hoc analyses revealed that across 2 months and 6 months, patients who were married/partnered were more likely to be abstinent after SRP than UC (P = .03).
CONCLUSIONS:
A smoking relapse prevention intervention did not reduce relapse rates overall, but did appear to have benefited those participants who had the social support of a partner. Future work is needed to extend this effect to the larger population of patients.
Keywords: cancer patients, intervention, relapse prevention, smoking
INTRODUCTION
A major modifiable risk factor for cancer is smoking, which contributes to approximately 30% of all cancer-related mortality.1 Smoking contributes to the development of cancer, worsens the disease state, interferes with treatment efficacy, complicates healing and recovery from surgery, and increases the risk of disease recurrence.1-5 Persistent smoking increases cancer-related and all-cause mortality.1 Although approximately 70% of patients with cancer who smoke attempt to quit at the time of diagnosis,1,6,7 up to 60% relapse.8-10 Given the acute and long-term risks, an effective intervention to prevent smoking relapse would be a valuable addition to the clinical armamentaria.
Factors contributing to relapse among the general population include negative mood, cravings, and withdrawal symptoms.11 Patients with cancer have unique or heightened stressors that impact quitting success, such as high nicotine dependence,12 treatment fatigue and concerns about cancer,13 symptoms of anxiety and depression,12,14,15 fears about cancer recurrence,9,14 and lack of partner support.16 To the best of our knowledge, relatively few interventions to date have examined the effectiveness of smoking relapse prevention (SRP) interventions in the general population,17 and no intervention trials have focused on relapse prevention in patients with cancer.
The current study tested the efficacy of a relapse prevention intervention comprising an educational DVD entitled Surviving SmokeFree that was specifically designed for patients with cancer18 and a self-help relapse prevention intervention (Forever Free) that is reported to be efficacious and cost-effective among the general population.19 Forever Free comprises a series of self-help booklets addressing a variety of topics related to relapse prevention. The booklets are distributed to recent quitters over time, thus supporting long-term smoking abstinence.19-21 The self-help modality maximizes dissemination and scalability potential. The Forever Free booklets and Surviving SmokeFree DVD target common and cancer-specific relapse risk factors, respectively.
MATERIALS AND METHODS
Participants
Participants were recently diagnosed patients with cancer who were initiating treatment at the H. Lee Moffitt Cancer Center in Tampa, Florida, who met the following criteria: 1) aged ≥18 years; 2) able to read and write in English and provide informed consent; 3) smoking history of ≥10 cigarettes per day over the past year; and 4) had quit since diagnosis and had been continuously abstinent for at least 24 hours but for ≤90 days at the time of recruitment. Patients with metastatic disease were excluded. Of the 596 patients who were screened for eligibility, 431 initially met the inclusion criteria and were randomized, with 412 patients (69%) completing the baseline and remaining eligible (Fig. 1).
FIGURE 1.
Consolidated Standards Of Reporting Trials (CONSORT) diagram.
Study Design
The 2-arm, parallel design compared usual care (UC) with the SRP intervention.22 Assessments were completed at the time of enrollment and at 2 months, 6 months, and 12 months after enrollment. Table 1 shows the intervention and assessment distribution time points. The protocol was approved by the institutional review board of the University of South Florida. Methodological details have been described elsewhere.22
TABLE 1.
Study Time Line: Intervention Schedule and Assessments With the Numbers of Survivors and Missing Surveys
| Month | 0 | 1 | 2 | 3 | 4 to 5 | 6 | 7 to 11 | 12 |
|---|---|---|---|---|---|---|---|---|
| Intervention | DVD FFB1 | FFB2 FFB3 FFB4 | FFB5 FFB6 | FFB7 FFB8 | ||||
| UC and SRP assessment | BA | FA-2 | FA-6 | FA-12 | ||||
| No. of survivors | 412 (100%) | 400 (97%) | 381 (92%) | 356 (86%) | ||||
| No. of missing surveys | 0 (0%) | 43 (11%) | 59 (15%) | 83 (23%) |
Abbreviations: BA, baseline assessment; DVD, Surviving SmokeFree DVD; FA-#, follow-up assessment month; FFB#, Forever Free Booklet number mailed; intervention, SRP intervention component distributed; SRP, smoking relapse prevention; UC, usual care.
The current study was registered with ClinicalTrials.gov (ClinicalTrials.gov identifier NCT01630161) on June 28, 2012.
Procedure
Prospective participants were identified by study staff via medical chart reviews or by the institution’s certified tobacco treatment specialist (TTS) during inpatient stays or outpatient appointments. A staff member assessed eligibility, obtained consent, and collected baseline data. Eligible patients were randomly assigned to either UC or the SRP (the TTS was blinded to assignments). The randomization was conducted using a balance permuted block (10) design with stratification by sex, length of smoking abstinence (ie, <7 days or ≥7 days), and cancer site (ie, thoracic, head and neck, or other). Study participants received compensation based on the number of completed assessments ($25-$125).
Usual care
Participants received UC/standard care for smoking cessation, which included a brief single session in which the TTS assessed the patient’s smoking status, advised them to quit or remain abstinent if they recently quit, assessed motivation, and provided assistance as needed (eg, pharmacotherapy) mirroring the 5-As model (Ask, Advise, Assess, Assist, and Arrange).23,24 Although UC was not a relapse prevention intervention, elements of relapse prevention often were included (ie, reinforcing motivation to remain abstinent).
Smoking relapse prevention
The development of the intervention materials is described elsewhere. 18,22 The original Forever Free intervention includes 8 booklets: a general overview followed by specific topics (“Smoking Urges”; “Smoking and Weight”; “What if You Have a Cigarette?”; “Your Health”; “Smoking, Stress, and Mood”; “Lifestyle Balance”; and “Life Without Cigarettes”). To elevate salience and engagement, a DVD was created with testimonials from actual patients, advice from oncologists, and motivational messages aimed at the specific needs of the oncology population.
Participants received both UC/standard care and the SRP intervention. Patients viewed the DVD in the clinic, where they also received a copy of the DVD and the initial Forever Free booklet. The remaining 7 booklets were mailed over a 3-month period (Table 1).
Measures
Baseline assessment
Clinical characteristics were extracted from medical charts. Demographics and history of tobacco use were acquired using self-report surveys. Similar to prior relapse prevention studies,19-21 when participants completed the Fagerstrom Test for Nicotine Dependence,25 they were asked to respond retrospectively to when they smoked regularly. Validated measures assessed fears of cancer recurrence26 and risk perception of smoking after cancer.27 Depressive symptoms were measured using the Center for Epidemiologic Studies Depression Scale (CES-D).28 The situation-specific abstinence self-efficacy measure assessed cessation self-efficacy.29 A 7-point Likert scale assessed confidence in not smoking within the next 6 months. Pain and fatigue were assessed using the Brief Pain Inventory30 and the Brief Fatigue Inventory,31 respectively.
Follow-up assessments
Target completion dates were 2 months, 6 months, and 12 months. The majority of assessments were conducted by telephone, with in-person or mailed assessments completed as needed. The surveys assessed smoking behavior and attitudes. At 2 months and 6 months, surveys for the SRP group assessed use of and satisfaction with the intervention.
Smoking status
The primary outcome variable was self-reported 7-day point prevalence abstinence (ie, no smoking within the previous 7 days). Participants who were receiving follow-up care at the institution or living within 50 miles and reporting abstinence at 6 months or 12 months were approached to obtain breath carbon monoxide (CO) samples collected via a portable CO monitor (Vitalograph Inc, Lenexa, Kansas); 8 parts per million (ppm) was the cutoff value for abstinence verification.32
Statistical Analyses
Descriptive statistics by condition were computed for demographic, clinical, smoking-related, and psychosocial variables measured at baseline. The distribution of some variables (eg, confidence) warranted dichotomization for analysis. To aid in interpretation of the findings and for managing missing data, preliminary analyses compared: 1) baseline data of the participants who survived versus those who were dead at 6 months; and 2) missing data at 2 months and 6 months among survivors. As used in other studies,21,33 missing data were managed using multiple imputation by applying the multivariate normal model given the missing data patterns and the characteristics of the primary variables.
Primary outcome analyses used generalized estimating equations to evaluate the effects of the SRP intervention on smoking at 2 months and 6 months for patients who survived through 6 months. A second analysis was performed to evaluate effects at 12 months for patients who survived through 12 months. The main predictors were condition, time, and their interaction. Any baseline variable found to differ by condition (P < .10) was included in the model. Prospective moderators were evaluated by adding the moderator and its interaction with the condition to the model for survivors through 6 months. Hypotheses were tested with an α of .05. An a priori sample size analysis indicated that a sample of 165 per group would provide 80% power to detect a difference in relapse between conditions of 40% versus 25% using the 2-sided Fisher exact test, with α = .05. Accrual of 414 participants was targeted with anticipated 20% attrition.
RESULTS
Participant Characteristics
Of the 412 patients with cancer who were enrolled, 31 had died by the 6-month assessment and were not included in the main analyses. Table 2 presents demographic, clinical, smoking-related, and psychosocial variables, by condition, for the 381 participants. In brief, approximately one-half of the participants were female, the majority were non-Hispanic White, and greater than one-half were married/partnered. The mean age of the patients was 55 years (SD, 11 years). Greater than one-half of patients had cancer diagnosed in the thoracic, head and/or neck, or gastrointestinal regions. Approximately one-third had a late-stage diagnosis. Participants had smoked for a mean of 35 years, averaging 21 cigarettes per day.
TABLE 2.
Baseline Sample Characteristics by Treatment Arm
| SRP, n = 191 |
UC, n = 190 |
Total, n = 381 |
|
|---|---|---|---|
| Characteristic | Mean (SD)/No. (%) | Mean (SD)/No. (%) | Mean (SD)/No. (%) |
| Femalea | 99 (51.8%) | 99 (52.1%) | 198 (52.0%) |
| Age, ya | 55.0 (11.0) | 55.2 (10.6) | 55.0 (10.8) |
| Race | |||
| White | 181 (95.3%) | 171 (90.0%) | 352 (92.6%) |
| Black/African American | 3 (1.6%) | 10 (5.3%) | 13 (3.4%) |
| Other | 6 (3.2%) | 9 (4.7%) | 15 (3.9%) |
| Hispanic ethnicity | 13 (7.0%) | 13 (7.2%) | 26 (7.1%) |
| White, non-Hispanica | 173 (90.6%) | 162 (85.3%) | 335 (87.9%) |
| Married/living togethera | 107 (56.0%) | 101 (53.2%) | 208 (54.6%) |
| Education >High schoola | 99 (52.7%) | 102 (55.4%) | 201 (54.0%) |
| Income >$30,000/ya | 104 (57.1%) | 97 (55.8%) | 201 (57.0%) |
| Employeda | 112 (60.2%) | 101 (54.6%) | 213 (57.4%) |
| Cancer site | |||
| Thoracic | 40 (20.9%) | 33 (17.4%) | 73 (19.2%) |
| Head and neck | 36 (18.8%) | 35 (18.4%) | 71 (18.6%) |
| Gastrointestinal | 24 (12.6%) | 30 (15.8%) | 54 (14.2%) |
| Breast | 22 (11.5%) | 26 (13.7%) | 48 (12.6%) |
| Genitourinary | 24 (12.6%) | 15 (7.9%) | 39 (10.2%) |
| Gynecological | 19 (9.9%) | 14 (7.4%) | 33 (8.7%) |
| Hematological | 13 (6.8%) | 24 (12.6%) | 37 (9.7%) |
| Cutaneous | 9 (4.7%) | 8 (4.7%) | 17 (4.5%) |
| Other | 4 (2.1%) | 5 (2.6%) | 9 (2.4%) |
| TNM disease stage | |||
| Unstaged | 15 (7.9%) | 32 (16.8%) | 47 (12.3%) |
| Stage 0 | 7 (3.7%) | 2 (1.1%) | 9 (2.4%) |
| Early (stage I-II) | 111 (58.1%) | 87 (45.8%) | 198 (52.0%) |
| Late (stage III-IV) | 58 (30.4%) | 69 (36.3%) | 127 (33.3%) |
| ECOG rating | |||
| Fully active | 98 (51.3%) | 93 (49.0%) | 191 (50.1%) |
| Restricted | 61 (31.9%) | 71 (37.3%) | 132 (34.7%) |
| Ambulatory | 12 (6.3%) | 12 (6.3%) | 24 (6.3%) |
| Limited | 0 (0.0%) | 3 (1.6%) | 3 (0.8%) |
| Not applicable | 20 (10.5%) | 11 (5.8%) | 31 (8.1%) |
| Brief Pain Inventory: severity (0-40) | 14.6 (10.0) | 16.2 (10.7) | 15.3 (10.4) |
| Brief Fatigue Inventory: severity (0-30) | 15.5 (8.7) | 16.3 (8.7) | 15.9 (8.7) |
| Has a comorbidity | 70 (36.7%) | 68 (35.8%) | 138 (36.2%) |
| No. of cigarettes/d | 21.6 (9.5) | 19.7 (9.1) | 20.6 (9.3) |
| No. of y smoking | 35.0 (12.5) | 34.3 (11.7) | 34.6 (12.1) |
| Fagerström Test for Nicotine | 5.3 (2.1) | 5.0 (2.2) | 5.2 (2.1) |
| Dependencea | |||
| Quit smoking when diagnoseda | 89 (48.6%) | 93 (50.3%) | 182 (49.5%) |
| 7-d point prevalent abstinenta | 134 (70.2%) | 128 (67.4%) | 262 (68.8%) |
| Using pharmacotherapy as a quit aid | 58 (30.4%) | 60 (31.6%) | 118 (31.0%) |
| Extremely confident abstinent in 6 moa | 91 (48.4%) | 106 (56.7%) | 197 (52.5%) |
| Quitting self-efficacy (9-45)a | 38.0 (7.6) | 38.3 (7.6) | 38.2 (7.6) |
| Fears about cancer (4-20) | 9.7 (3.8) | 10.3 (3.8) | 10.0 (3.8) |
| Perceived risk of cancer recurrence (7-28) | 22.9 (4.3) | 22.5 (4.4) | 22.7 (4.3) |
| Depression (8-32) | 15.9 (5.9) | 16.8 (5.9) | 16.3 (5.9) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; SRP, smoking relapse prevention; UC, usual care.
There were no statistically significant differences noted between the groups.
Values were based on available responses; some items were not completed by all patients.
Variable was evaluated as a prospective moderator; the variable and its interaction with the condition were included in the multiple imputation model.
Those participants who had died by the time of the 6-month survey were more likely to be men (71% vs 48%; P = .01), to have late-stage disease (86% vs 38%; P < .001), and to report extreme confidence in not smoking at 6 months from baseline (74% vs 53%; P = .02).
Missing Data
The 2-month and 6-month surveys were both completed by 309 participants; 29 participants completed neither, 14 participants were missing only at 2 months, and 29 participants were missing only at 6 months. The multivariate normal model for multiple imputation included condition, smoking status at the time of each follow-up, 12 prospective moderators (see Table 2), and 12 variables representing the interaction of the moderator with the condition. Twenty data sets were generated and analyzed.
Abstinence Rates at the 2-Month and 6-Month Follow-Up
As shown in Table 3, the overall 7-day point prevalence abstinence rate from the imputed data sets was approximately 73% at 2 months and 67% at 6 months, with higher abstinence rates of approximately 4% for the SRP condition at both assessments. Generalized estimating equations analyses revealed a main effect for month (P = .001). However, the overall greater abstinence rate in the SRP condition was not found to be statistically significant (P = .20), nor were comparisons at each assessment point (ps > .20).
TABLE 3.
Percentage Abstinent at 2 Months, 6 Months, and 12 Months
| Assessment/Group | SRP | UC | Pa | OR (95% CI)b |
|---|---|---|---|---|
| 2 moc | ||||
| All participants | 75.0% | 71.5% | .202 | 1.37 (0.85-2.23) |
| Married/living together | 87.9% | 76.7% | .046 | 2.23 (1.01-4.90) |
| Not married/living together | 62.3% | 63.9% | .801 | 0.94 (0.50-1.80) |
| 6 moc | ||||
| All participants | 68.8% | 64.8% | .300 | 1.27 (0.81-2.00) |
| Married/living together | 78.6% | 66.4% | .061 | 1.86 (0.97-3.56) |
| Not married/living together | 58.3% | 62.0% | .634 | 0.86 (0.45-1.62) |
| 12 mod | ||||
| All participants | 67.5% | 62.7% | .384 | 1.24 (0.77-2.00) |
| Married/living together | 73.7% | 72.2% | .838 | 1.08 (0.52-2.18) |
| Not married/living together | 59.9% | 53.2% | .427 | 1.31 (0.67-2.58) |
Abbreviations: OR, odds ratio; SRP, smoking relapse prevention; UC, usual care.
P value was for the score statistic of the planned contrast at that assessment within the broader generalized estimating equations model.
OR estimates were based on logistic regression analysis for the specific assessment.
Percentage abstinent was the average across 20 data sets generated by multiple imputation for the 381 survivors at 6 months. The P value was for the planned comparison within a generalized estimating equations model for 2 months and 6 months.
Percentage abstinent was the average across 20 data sets generated by multiple imputation for the 356 survivors at 12 months.
Of the 12 prospective moderators, only marital/partnered status demonstrated a marginally significant interaction with condition (P = .07) on abstinence rates over the 2 assessments (Table 3). Overall, among married/partnered patients, SRP yielded higher abstinence rates compared with UC (83% vs 72%; P = .03), with no group differences found for those not married/partnered (60% vs 63%; P = .71). Unmarried/unpartnered patients reported worse pain, fatigue, and depression than married/partnered patients, as well as lower quitting confidence and lower perceived risk (ps < .05).
Abstinence Rates at the 12-Month Follow-Up (9 Months After the Intervention)
At 12 months, 273 of the 356 survivors had completed the survey. Given the change in the number of survivors and the large increase in missing surveys, a separate multiple imputation was performed prior to analyzing smoking status at 12 months. Average abstinence rates were 68% for participants in the SRP group and 63% for participants in the UC group. A planned contrast revealed the difference was not statistically significant (P = .38). Similarly, the difference between the SRP and UC groups among participants who were married/partnered was not found to be statistically significant (P = .84).
Biochemical Verification
At 6 months, a total of 230 participants reported abstinence, 185 of whom received follow-up care at the institution or lived within 50 miles of the hospital. Of those participants, 162 provided data, with 12.3% having CO levels ≥8 ppm. At 12 months, 187 participants were abstinent, 145 of whom received follow-up care at the institution or were living within 50 miles of the hospital. Of those, 134 provided data, with 12.7% producing CO values ≥8 ppm.
Intervention Use and Evaluation
Items evaluating use of and satisfaction with the intervention were included in the 2-month and 6-month assessments. Use and satisfaction ratings were found to be consistent across both assessments. At 6 months, approximately 78% of participants reported reading the booklets at least once, and 25% reported viewing the DVD again. At 6 months, for example, 95% of participants rated the quality of the DVD content as very or mostly good; 87% rated the information provided as somewhat, mostly, or all new; and 86% rated it as somewhat or very helpful. For the booklets, 98% of participants rated the content as very or mostly good; 87% rated the information as somewhat, mostly, or all new; and 84% rated the materials as somewhat or very helpful.
DISCUSSION
To the best of our knowledge, the current study is the first to examine the efficacy of a smoking relapse prevention intervention for patients with cancer. The self-help intervention was well received by patients and resulted in abstinence percentages that were 4 to 5 points higher compared with UC, yet the differences were not significant. Previous trials have failed to increase smoking cessation intervention effects for patients with cancer.8,34,35The results of the current study appeared to extend this record of nonsignificant outcomes to SRP. The findings confirm the challenges in producing changes in smoking among patients with cancer. Moderator analyses demonstrated a marginally significant intervention benefit among married/partnered patients.
Smoking relapse is a common phenomenon after a quit attempt, and only approximately 3% to 5% of smokers trying to quit stay abstinent for 6 to 12 months.36 Our previous SRP booklets tested with smokers in the general population produced significant reductions in relapse rates, which motivated the current study.19,20 However, the inability of the current intervention to reduce smoking relapse among patients with cancer is in contrast to the efficacy findings from these earlier studies.19-21 However, one difference is that the prior studies often distributed the intervention materials over a 12-month period. Given the acute health concerns of patients with cancer, the distribution of materials was abbreviated to 3 months herein. Recent research has demonstrated the usefulness of increasing contact intensity and extending the distribution of self-help interventions over 18 months.33 It is possible that abbreviating the distribution schedule reduced the potential efficacy of the intervention.
The intervention may have been insufficiently tailored for patients with cancer. Although the Surviving SmokeFree DVD was created for this population, the Forever Free booklets were generic. Tailoring may produce greater perceived relevance, engagement, and efficacy, albeit at a greater cost.
The absence of a treatment effect also may be related to the addition of the intervention to meaningful standard care, namely assistance from the TTS. The original Forever Free relapse prevention booklets were developed for and demonstrated efficacy among self-quitting smokers. Later studies that added the intervention to existing Quitline or in-person cessation counseling did not appear to increase efficacy.37,38 When superimposed on an effective cessation intervention, self-help interventions may have minimal additional benefit.
The results of the current study suggested that the intervention was effective for those participants who were married/partnered. Perceived social support has been a consistent predictor of successful smoking cessation.39 Providing materials for sources of support21,40 or pamphlets with first-person accounts of cessation experiences35 might boost intervention effects. In the current study sample, those without spouses/partners reported higher pain, fatigue, and depression, and lower confidence in quitting. This may impede efforts at tobacco abstinence, thereby blunting any intervention effects.
To the best of our knowledge, the current study represents one of the largest trials to date with diverse cancer diagnoses, yet the study sample was smaller than is often used for self-help smoking cessation and relapse prevention trials or population-based trials,19-21,36 which limited its statistical power. However, if the observed 5% difference in abstinence rates was robust across cancer centers, the result would be clinically meaningful and would improve cancer outcomes for a substantial number of patients. Finally, abstinence rates should be considered within the context of the discrepancy between self-reported abstinence and biochemical verification (approximately 12% misreporting).
As noted by Croyle et al,41 smoking cessation should be a fundamental component of cancer care. To draw much needed attention to this area, the National Cancer Institute, as part of the Cancer Moonshot, initiated the Cancer Center Cessation Initiative to provide funding to National Cancer Institute–designated cancer centers to deliver smoking cessation treatment to this group considered to be at high risk. Future studies should investigate: 1) increasing the intensity and duration of the intervention; 2) increasing the degree of cancer-specific tailoring; 3) including materials designed to increase partner support42; 4) broadening the inclusion criteria with respect to nicotine dependence; and 5) intervention effects on a more ethnically and/or racially diverse patient population. Despite the well-justified motivation of many patients with cancer to achieve and maintain smoking abstinence, there continues to be a strong need to develop and test tobacco interventions in the oncology setting.
Acknowledgments
FUNDING SUPPORT
Funded by the National Institutes of Health (grant R01CA154596) and supported by the Biostatistics and Bioinformatics Shared Resource at the H. Lee Moffitt Cancer Center and Research Institute, a National Cancer Institute–designated comprehensive cancer center (grant P30CA76292). The content of this article does not necessarily represent the opinion or policy of the National Cancer Institute.
Footnotes
CONFLICT OF INTEREST DISCLOSURES
Vani N. Simmons has received grants from the National Institutes of Health for work performed as part of the current study. Steven K. Sutton, Lauren R. Meltzer, Ursula Martinez, Amanda M. Palmer, Cathy D. Meade, Paul B. Jacobsen, and Judith C. McCaffrey have received grants from the National Cancer Institute for work performed as part of the current study. Eric B. Haura received grants from the National Cancer Institute for work performed as part of the current study and has acted as a paid consultant for Amgen, Ellipses, and Janssen for work performed outside of the current study. Thomas H. Brandon received grants from the National Cancer Institute for work performed as part of the current study, has received research support from Pfizer Inc, and serves on the advisory board of and owns restricted stock in Hava Health Inc.
REFERENCES
- 1.US Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. [Google Scholar]
- 2.Florou AN, Gkiozos IC, Tsagouli SK, Souliotis KN, Syrigos KN. Clinical significance of smoking cessation in subjects with cancer: a 30-year review. Respir Care. 2014;59:1924–1936. [DOI] [PubMed] [Google Scholar]
- 3.Videtic GM, Stitt LW, Dar AR, et al. Continued cigarette smoking by patients receiving concurrent chemoradiotherapy for limited-stage small-cell lung cancer is associated with decreased survival. J Clin Oncol. 2003;21:1544–1549. [DOI] [PubMed] [Google Scholar]
- 4.Fox JL, Rosenzweig KE, Ostroff JS. The effect of smoking status on survival following radiation therapy for non–small cell lung cancer. Lung Cancer. 2004;44:287–293. [DOI] [PubMed] [Google Scholar]
- 5.Kawahara M, Ushijima S, Kamimori T, et al. Second primary tumours in more than 2-year disease-free survivors of small-cell lung cancer in Japan: the role of smoking cessation. Br J Cancer. 1998;78:409–412. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Tseng TS, Lin HY, Moody-Thomas S, Martin M, Chen T. Who tended to continue smoking after cancer diagnosis: the National Health and Nutrition Examination Survey 1999-2008. BMC Public Health. 2012;12:784. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Westmaas JL, Newton CC, Stevens VL, Flanders WD, Gapstur SM, Jacobs EJ. Does a recent cancer diagnosis predict smoking cessation? An analysis from a large prospective US cohort. J Clin Oncol. 2015;33:1647–1652. [DOI] [PubMed] [Google Scholar]
- 8.Gritz ER, Fingeret MC, Vidrine DJ, Lazev AB, Mehta NV, Reece GP. Successes and failures of the teachable moment. Cancer. 2006;106:17–27. [DOI] [PubMed] [Google Scholar]
- 9.Simmons VN, Litvin EB, Jacobsen PB, et al. Predictors of smoking relapse in patients with thoracic cancer or head and neck cancer. Cancer. 2013;119:1420–1427. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Walker MS, Vidrine DJ, Gritz ER, et al. Smoking relapse during the first year after treatment for early-stage non–small-cell lung cancer. Cancer Epidemiol Biomarkers Prev. 2006;15:2370–2377. [DOI] [PubMed] [Google Scholar]
- 11.Robinson JD, Li L, Chen M, et al. Evaluating the temporal relationships between withdrawal symptoms and smoking relapse. Psychol Addict Behav. 2019;33:105–116. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Chang EHE, Braith A, Hitsman B, Schnoll RA. Treating nicotine dependence and preventing smoking relapse in cancer patients. Expert Rev Qual Life Cancer Care. 2017;2:23–39. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Gritz ER, Schacherer C, Koehly L, Nielsen IR, Abemayor E. Smoking withdrawal and relapse in head and neck cancer patients. Head Neck. 1999;21:420–427. [DOI] [PubMed] [Google Scholar]
- 14.Guimond AJ, Croteau VA, Savard MH, Bernard P, Ivers H, Savard J. Predictors of smoking cessation and relapse in cancer patients and effect on psychological variables: an 18-month observational study. Ann Behav Med. 2017;51:117–127. [DOI] [PubMed] [Google Scholar]
- 15.Walker MS, Larsen RJ, Zona DM, Govindan R, Fisher EB. Smoking urges and relapse among lung cancer patients: findings from a preliminary retrospective study. Prev Med. 2004;39:449–457. [DOI] [PubMed] [Google Scholar]
- 16.Poghosyan H, Darwish SA, Kim SS, Cooley ME. The association between social support and smoking status in cancer survivors with frequent and infrequent mental distress: results from 10 US states, 2010. J Cancer Surviv. 2016;10:1078–1088. [DOI] [PubMed] [Google Scholar]
- 17.Livingstone-Banks J, Norris E, Hartmann-Boyce J, et al. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019;2019:CD003999. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Meltzer LR, Meade CD, Diaz DB, et al. Development of a targeted smoking relapse-prevention intervention for cancer patients. J Cancer Educ. 2016;33, 440–447. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Brandon TH, Meade CD, Herzog TA, Chirikos TN, Webb MS, Cantor AB. Efficacy and cost-effectiveness of a minimal intervention to prevent smoking relapse: dismantling the effects of amount of content versus contact. J Consult Clin Psychol. 2004;72:797–808. [DOI] [PubMed] [Google Scholar]
- 20.Brandon TH, Collins BN, Juliano LM, Lazev AB. Preventing relapse among former smokers: a comparison of minimal interventions through telephone and mail. J Consult Clin Psychol. 2000;68:103–113. [DOI] [PubMed] [Google Scholar]
- 21.Brandon TH, Simmons VN, Meade CD, et al. Self-help booklets for preventing postpartum smoking relapse: a randomized trial. Am J Public Health. 2012;102:2109–2115. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Diaz DB, Brandon TH, Sutton SK, et al. Smoking relapse-prevention intervention for cancer patients: study design and baseline data from the surviving SmokeFree randomized controlled trial. Contemp Clin Trials. 2016;50:84–89. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence: Clinical Practice Guideline. US Department of Health and Human Services; 2000. [Google Scholar]
- 24.Fiore MC, Jaen CR, Baker T, et al. Treating Tobacco Use and Dependence: 2008 Update. US Department of Health and Human Services; 2008. [Google Scholar]
- 25.Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991;86:1119–1127. [DOI] [PubMed] [Google Scholar]
- 26.Greenberg DB, Kornblith AB, Herndon JE, et al. Quality of life for adult leukemia survivors treated on clinical trials of Cancer and Leukemia Group B during the period 1971-1988: predictors for later psychologic distress. Cancer. 1997;80:1936–1944. [DOI] [PubMed] [Google Scholar]
- 27.Schnoll RA, James C, Malstrom M, et al. Longitudinal predictors of continued tobacco use among patients diagnosed with cancer. Ann Behav Med. 2003;25:214–222. [DOI] [PubMed] [Google Scholar]
- 28.Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1:385–401. [Google Scholar]
- 29.Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15:271–283. [DOI] [PubMed] [Google Scholar]
- 30.Cleeland C Measurement of pain by subjective report. Adv Pain Res Ther. 1989;12:391–403. [Google Scholar]
- 31.Mendoza TR, Wang XS, Cleeland CS, et al. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999;85:1186–1196. [DOI] [PubMed] [Google Scholar]
- 32.SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002;4:149–159. [DOI] [PubMed] [Google Scholar]
- 33.Cinciripini PM, Karam-Hage M, Kypriotakis G, et al. Association of a comprehensive smoking cessation program with smoking abstinence among patients with cancer. JAMA Netw Open. 2019;2:e1912251. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 34.Sheeran P, Jones K, Avishai A, et al. What works in smoking cessation interventions for cancer survivors? A meta-analysis. Health Psychol. 2019;38:855–865. [DOI] [PubMed] [Google Scholar]
- 35.Brandon TH, Simmons VN, Sutton SK, et al. Extended self-help for smoking cessation: a randomized controlled trial. Am J Prev Med. 2016;51:54–62. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 36.Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004;99:29–38. [DOI] [PubMed] [Google Scholar]
- 37.Unrod M, Simmons VN, Sutton SK, et al. Relapse-prevention booklets as an adjunct to a tobacco quitline: a randomized controlled effectiveness trial. Nicotine Tob Res. 2016;18:298–305. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 38.Maskrey V, Blyth A, Brown TJ, et al. Self-help educational booklets for the prevention of smoking relapse following smoking cessation treatment: a randomized controlled trial. Addiction. 2015;110:2006–2014. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 39.Westmaas JL, Bontemps-Jones J, Bauer JE. Social support in smoking cessation: reconciling theory and evidence. Nicotine Tob Res. 2010;12:695–707. [DOI] [PubMed] [Google Scholar]
- 40.Pineiro B, Diaz DR, Monsalve LM, et al. Systematic transcreation of self-help smoking cessation materials for Hispanic/Latino smokers: improving cultural relevance and acceptability. J Health Commun. 2018;23:350–359. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 41.Croyle RT, Morgan GD, Fiore MC. Addressing a core gap in cancer care–the NCI Moonshot program to help oncology patients stop smoking. N Engl J Med. 2019;380:512–515. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 42.Faseru B, Richter KP, Scheuermann TS, Park EW. Enhancing partner support to improve smoking cessation. Cochrane Database Syst Rev. 2018;8:CD002928. [DOI] [PMC free article] [PubMed] [Google Scholar]