Slide 1 77.8% 52.0% 22.2% 48.0% 0 5 10 15 20 25 Received Book (n = 27) Recommended Book (n = 25) N u m b e r o f P a rt ic ip a n ts Book Status vs. Amount of Book Read Read at Least Some of Book Did Not Read Book Prospective Randomized Control Trial Using Best-Selling Smoking Cessation Book James Foshee; Anita Oh, MD; Adam Luginbuhl, MD; Joseph Curry, MD; William Keane, MD; David Cognetti, MD Thomas Jefferson University Hospital, Department of Otolaryngology – Head and Neck Surgery Patients recruited between April 2012 and August 2013 • Patients with long-term follow-up scheduled before Sept. 2013 eligible for follow-up • 3 patients voluntarily unenrolled • 10 patients could not be reached for follow-up • 6 patients had disconnected or non- working phone numbers • 1 patient died during the course of the study • 6 patients voluntarily unenrolled • 10 patients could not be reached for follow-up • 5 patients had disconnected or non-working phone numbers Abstract: This study aimed to evaluate the efficacy of the educational, self-help book The Easy Way to Stop Smoking by Allen Carr in achieving smoking cessation in patients being screened or currently being treated for cancers of the head and neck. A prospective, randomized control trial was conducted involving 112 patients being screened or undergoing treatment for head and neck cancer at the Thomas Jefferson University Hospital Department of Otolaryngology. Participants completed surveys assessing readiness to quit smoking, amount of tobacco usage, and amount of time actively smoking. The Easy Way to Stop Smoking was provided to half of the participants, while the other half received a recommendation to purchase the book. All patients received physician directed smoking cessation counseling. Phone surveys were conducted at short and long-term follow-up intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. Of the 112 patients recruited, 93 were eligible for follow-up, and only 52 completed the long-term follow-up survey. The remaining participants were lost to follow-up for various reasons. Those who received the book for free were more likely to read at least some of the book, p = 0.05, although reading the book did not appear to correlate with successful smoking cessation, p = 0.81. Only 26% of patients who received the book (n = 27) quit, while 32% of patients (n = 25) who were recommended the book quit smoking, although this difference was not significant, p = 0.76. Patients who indicated “readiness” or “actively trying” to quit (n = 42) appeared more likely to be successful than those who would only “consider” quitting (n = 10), but the differences were not significant, p = 0.70. Smoking cessation rates did not appear to be impacted by reading Allen Carr’s The Easy Way to Stop Smoking. Cessation rates between groups who read and did not read the book were similar, and the small differences were not statistically significant. Despite a majority of the cohort indicating at least a readiness to quit smoking, only a small portion of patients managed to achieve successful smoking cessation. This study seems to support the notion that there is no single method to promote cessation, and that patient motivation remains an important factor in achieving long-term smoking abstinence. Introduction: Smoking is the most common preventable risk factor in the development of head and neck cancers[1]. Patients who smoke can be up to 25 times more likely to develop cancers of the head and neck than non-smokers[1]. Oral cancer patients who continue to smoke are also at increased risk for developing additional primary malignancies[2]. Smoking cessation can reduce the risk of oral cancer by 50% within the first five years. After ten years, the risk of developing oral cancer approaches the risk of non-smokers[3]. As such, it is extremely important to promote smoking cessation counseling in all patients who smoke, particularly those who have already been diagnosed with a head and neck malignancy. Even after diagnosis, successful smoking cessation can improve survival rates. There are a variety of programs and interventions aimed at smoking cessation, although maintaining smoking abstinence is always a challenge. Printed education materials have been found to improve physician practices, but their efficacy is as of yet inconclusive for patient outcomes[4]. In the Thomas Jefferson University Hospital Department of Otolaryngology, we believe one method that may be effective in convincing patients to quit smoking is the best-selling self-help book The Easy Way to Stop Smoking, by Allen Carr. This book explores the reasons people smoke, aiming to change smoker’s feelings about their addictions and challenge misconceptions in order to promote cessation. This study aimed to evaluate the efficacy of the educational, self-help book The Easy Way to Stop Smoking by Allen Carr in achieving smoking cessation in patients being screened or currently being treated for cancers of the head and neck. Additionally, this study aimed to determine if providing the book for free improved the likelihood patients would read the book over recommending the purchase of the book. Methods: Study participants over the age of 18 were recruited during office visits to the Thomas Jefferson University Hospital – Department of Otolaryngology. Current smokers who either underwent screening or were actively being treated for cancers of the head and neck were eligible for recruitment in this study. Consenting participants were randomized into two treatment groups: Intervention Group: received physician counseling on smoking cessation with a recommendation to purchase the book The Easy Way to Stop Smoking by Allen Carr. Control Group: received physician smoking cessation counseling in addition to a free copy of the book The Easy Way to Stop Smoking Books were provided by research nurses to allow for adequate blinding of the study physicians. Recruited patients completed an “Intake Questionnaire” to determine, among other things, amount of cigarettes smoked per day, obstacles to quitting, family support, and readiness to quit smoking (evaluated on the following Likert scale): 1 = “Not planning to quit” 2 = “Would consider [quitting] if a reasonable solution was provided” 3 = “Ready to take action” 4 = “Actively trying to quit” After the initial intake survey, patients were followed-up via phone at short (two weeks to six months) and long term intervals (six months to one year). Timing of follow-ups depended on ability to reach the patients via phone. Discussion: The Easy Way to Quit Smoking does not appear to be an effective intervention to promote smoking cessation by itself. Reading the book did not appear to be associated with an increased likelihood to quit smoking. Interestingly, those patients who did not read the book at all had the highest percentage of smoking cessation (33.3%), as well as the highest mean cigarette reduction (52.5%), although neither of these values were statistically significant, p = 0.81 and p = 0.83, respectively. Additionally, those patients who read the entire book (compared to those who read some or none of the book) showed the lowest average cigarette reduction (43.7%), p = 0.83. A cancerous diagnosis correlated with a minor increase in the likelihood that patients would quit smoking, although it was not a significant difference, p = 0.76. These findings are inconsistent with the literature, as cancer has been shown to be an effective motivator for smoking cessation[5,6]. Anecdotally, several patients surveyed admitted their cancer diagnosis was the major reason for their smoking cessation, and not The Easy Way to Stop Smoking. Providing the intervention (i.e. Allen Carr’s book) free-of-charge ensured patients were more likely to utilize the intervention. Those who received the book free of charge from the TJUH Department of Otolaryngology were more likely to read the book (77.8%) than those who were only recommended to purchase the book (52%), p = 0.05. When suggesting other smoking cessation interventions, cost to the patient may be a factor affecting compliance. Identifying patients who are ready or motivated to quit smoking may be useful in targeting smoking cessation interventions, as these patients may be more likely to successfully quit smoking. Finding the motivation to quit seems to be a major obstacle in smoking cessation, and is supported in the literature[7]; those who are motivated to quit smoking are more likely to be successful. Many of the study participants enjoyed reading the book, although few managed to successfully quit smoking during the study. Patients who initially reported readiness to quit or were actively trying to quit smoking were successful in higher percentages (28.6% and 35.7%, respectively) than those who would only consider quitting (20%), p = 0.703. Despite a lack of statistical significance, these trends are certainly interesting. A similar study illustrated that patients with low motivation or low readiness to quit were unlikely to benefit from self-help materials, such as a smoking cessation book[8]. The small sample size and large participant attrition are limitations of this study. While some attrition was expected, we did not anticipate losing the number of patients we did (44%). Conducting the follow-up surveys via phone also presented challenges, as many of the study participants were either undergoing or recovering from treatment for head and neck cancers. Likely, the stress and hardships associated with a cancer diagnosis contributed to some of the participant loss. Another limitation was the study’s reliance on self-reported data collected in surveys. Patients have been known to underestimate their cigarette intake[9], and it’s entirely possible some patients may have overestimated the amount of the book they read. Conclusion: Nearly every patient surveyed that read the book enjoyed the The Easy Way to Stop Smoking, finding it both helpful and informative, although only a small percentage of patients managed to translate the book’s message into practice and achieve smoking cessation. Due to the small sample size, it is difficult to make any concrete conclusions about the efficacy of Allen Carr’s The Easy Way to Stop Smoking, although the small percentage of patients who did quit smoking suggests there is no single “magic-bullet” approach that can tackle the intense nature of nicotine addiction. Identifying a patient’s motivation to quit may be a useful tool in tailoring future cessation strategies and treatment, but achieving long-term smoking cessation still remains a major challenge to both patients and otolaryngologists. Any attempts at promoting smoking abstinence should likely involve a multi- faceted approach. F(2, 49) = 0.191, p = 0.83 Acknowledgements: Tara Difabio, Amy Wotlinksi, and Kristin Loeb for their help in recruiting study participants. Elizabeth Duddy for coordinating the study, as well as recruiting and following-up with study participants. Results: #5545 C2 (1, n = 52) = 3.81, p = 0.05 25.9% 32.0% 74.1% 68.0% 0 5 10 15 20 25 Received Book (n = 27) Recommended Book (n = 25) N u m b e r o f P a rt ic ip a n ts Book Status vs. Smoking Status Quit Smoking Did Not Quit Smoking 20% 28.60% 35.70% 0% 10% 20% 30% 40% 50% Would Consider Quitting (n = 10) Ready to Quit (n = 28) Actively Trying to Quit (n = 14) P a rt ic ip a n ts W h o Q u it S m o k in g ( % ) Readiness to Quit vs. Smoking Status 43.70% 44.70% 52.50% 40.0% 42.5% 45.0% 47.5% 50.0% 52.5% 55.0% Read Entire Book (n = 17) Read Some of Book (n = 17) Did Not Read Book (n = 18) M e a n C ig a re tt e R e d u c ti o n ( % ) Mean Cigarette Reduction vs. Amount of Book Read C2 (2, n = 52) = 0.70, p = 0.70 25% 8% 21% 8% 11% 4% 10% 13% Self-Reported Obstacles to Quitting Anxiety or Stress Exposure to smokers at work/home Craving for nicotine or Habit of Smoking Fears of weight gain, depression, or boredom Feels unable to quit or Lacks willpower Enjoy smoking or Does not want to quit No obstacle reported Multiple obstacles reported References: 1. Marur, Shanthi, and Arlene A Forastiere. “Head and Neck Cancer: Changing Epidemiology, Diagnosis, and Treatment.” Mayo Clinic Proceedings. Mayo Clinic 83, no. 4 (April 2008): 489–501. doi:10.4065/83.4.489. 2. Day, Terry A, Angela Chi, Brad Neville, and James R Hebert. “Prevention of Head and Neck Cancer.” Current Oncology Reports 7, no. 2 (March 2005): 145–153. 3. Marron M., Boffetta P., Zhang Z-F., et al. “Cessation of Alcohol Drinking, Tobacco Smoking and the Reversal of Head and Neck Cancer Risk.” Int J Epidemiol 39, (2010): 182–96. 4. Giguère, Anik, France Légaré, Jeremy Grimshaw, Stéphane Turcotte, Michelle Fiander, Agnes Grudniewicz, Sun Makosso-Kallyth, Fredric M Wolf, Anna P Farmer, and Marie-Pierre Gagnon. “Printed Educational Materials: Effects on Professional Practice and Healthcare Outcomes.” The Cochrane Database of Systematic Reviews 10 (2012). 5. Pinto, Bernardine M., Elizabeth Eakin, and Nancy C. Maruyama. “Health Behavior Changes after a Cancer Diagnosis: What Do We Know and Where Do We Go from Here?” Annals of Behavioral Medicine 22, no. 1 (March 1, 2000): 38-52. 6. Blanchard, Chris M., Maxine M. Denniston, Frank Baker, Stuart R. Ainsworth, Kerry S. Courneya, Danette M. Hann, Dean H. Gesme, Douglas Reding, Thomas Flynn, and John S. Kennedy. “Do Adults Change Their Lifestyle Behaviors After a Cancer Diagnosis?” American Journal of Health Behavior 27, no. 3 (May 1, 2003): 246–256. 7. Hymowitz, N, K M Cummings, A Hyland, W R Lynn, T F Pechacek, and T D Hartwell. “Predictors of Smoking Cessation in a Cohort of Adult Smokers Followed for Five Years.” Tobacco Control 6 Suppl 2 (1997): S57–62. 8. Dijkstra, A, H De Vries, and J Roijackers. “Targeting Smokers with Low Readiness to Change with Tailored and Nontailored Self-help Materials.” Preventive Medicine 28, no. 2 (February 1999): 203–211. 9. Morales, Nelson A, Michelle A Romano, K Michael Cummings, James R Marshall, Andrew J Hyland, Alan Hutson, and Graham W Warren. “Accuracy of Self-reported Tobacco Use in Newly Diagnosed Cancer Patients.” Cancer Causes & Control: CCC 24, no. 6 (June 2013): 1223–1230 32.0% 25.9% 68.0% 74.1% 0 5 10 15 20 25 Cancerous Diagnosis (n = 25) Non-cancerous Diagnosis (n = 27) N u m b e r o f P a rt ic ip a n ts Diagnosis vs. Smoking Status Quit Smoking Did Not Quit Smoking C2 (1, n = 52) = 0.23, p = 0.63 C2 (1, n = 52) = 0.23, p = 0.63 n = 52 C2 (2, n = 52) = 0.41, p = 0.81 29.4% 23.5% 33.3% 0% 10% 20% 30% 40% Read Entire Book (n = 17) Read Some of Book (n = 17) Did Not Read Book (n = 18) P a rt ic ip a n ts W h o Q u it S m o k in g ( % ) Amount of Book Read vs. Smoking Status