Skip to main content

Advertisement

SpringerLink
Log in

Issues related to implementing a smoking cessation clinical trial for cancer patients

  • Original Paper
  • Published:
Cancer Causes & Control Aims and scope Submit manuscript

Abstract

Given high rates of smoking among cancer patients, smoking cessation treatment is crucial; yet limited data exist to guide integration of such trials into the oncologic context. In order to determine the feasibility of conducting smoking cessation clinical trials with cancer patients, screening and baseline data from a large randomized placebo-controlled pharmacotherapy trial were analyzed. Descriptive statistics and regression analyses were used to compare enrollees to decliners, describe program enrollees, and assess correlates of confidence in quitting smoking. Out of 14,514 screened patients, 263 (<2%) were eligible; 43 (16%) refused enrollment. Among the eligible patients, 220 (84%) enrolled. Enrollment barriers included smoking rate, medical history/contraindicated medication, lack of interest, and language. Compared to enrollees, decliners were more likely to have advanced cancer. The trial enrolled a sample of 67 (>30%) African Americans; participants had extensive smoking histories; many were highly nicotine dependent; and participants consumed about seven alcoholic beverages/week on average. Head and neck and breast cancer were the most common tumors. About 52 (25%) reported depressive symptoms. A higher level of confidence to quit smoking was related to lower depression and lower tumor stage. Integrating a smoking cessation clinical trial into the oncologic setting is challenging, yet feasible. Recruitment strategies are needed for patients with advanced disease and specific cancers. Once enrolled, addressing participant’s depressive symptoms is critical for promoting cessation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Notes

  1. We also examined tumor site in terms of tobacco related [head and neck and lung cancer] versus other and did not find that this variable was related to enrollment status.

References

  1. Spitz MR, Fueger JJ, Chamberlain RM, Goepfert H, Newell GR (1990) Cigarette smoking patterns in patients after treatment of upper aerodigestive tract cancers. J Cancer Educ 5(2):109–113

    Article  PubMed  CAS  Google Scholar 

  2. Schnoll RA, James C, Malstrom M et al (2003) Longitudinal predictors of continued tobacco use among patients diagnosed with cancer. Ann Behav Med 25(3):214–221. doi:10.1207/S15324796ABM2503_07

    Article  PubMed  Google Scholar 

  3. Walker MS, Vidrine DJ, Gritz ER et al (2006) Smoking relapse during the first year after treatment for early-stage non-small-cell lung cancer. Cancer Epidemiol Biomarkers Prev 15(12):2370–2377. doi:10.1158/1055-9965.EPI-06-0509

    Article  PubMed  CAS  Google Scholar 

  4. Zhou W, Heist RS, Liu G et al (2006) Smoking cessation before diagnosis and survival in early stage non-small cell lung cancer patients. Lung Cancer 53(3):375–380. doi:10.1016/j.lungcan.2006.05.017

    Article  PubMed  Google Scholar 

  5. Garces YI, Schroeder DR, Nirelli LM et al (2007) Second primary tumors following tobacco dependence treatments among head and neck cancer patients. Am J Clin Oncol 30(5):531–539. doi:10.1097/COC.0b013e318059adfc

    Article  PubMed  Google Scholar 

  6. Browman GP, Wong G, Hodson I et al (1993) Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med 328(3):159–163. doi:10.1056/NEJM199301213280302

    Article  PubMed  CAS  Google Scholar 

  7. Carter CL, Key J, Marsh L, Graves K (2001) Contemporary perspectives in tobacco cessation: what oncologists need to know. Oncologist 6(6):496–505. doi:10.1634/theoncologist.6-6-496

    Article  PubMed  CAS  Google Scholar 

  8. Cinciripini PM, Gritz ER, Tsoh JY, Skaar KL (1998) Smoking cessation and cancer prevention. In: Holland JC (ed) Psycho-oncology. Oxford University Press, New York, pp 27–44

    Google Scholar 

  9. Des Rochers C, Dische S, Saunders MI (1992) The problem of cigarette smoking in radiotherapy for cancer in the head and neck. Clin Oncol (R Coll Radiol) 4(4):214–216. doi:10.1016/S0936-6555(05)81053-2

    CAS  Google Scholar 

  10. Vander Ark W, DiNardo LJ, Oliver DS (1997) Factors affecting smoking cessation in patients with head and neck cancer. Laryngoscope 107(7):888–892. doi:10.1097/00005537-199707000-00010

    Article  PubMed  CAS  Google Scholar 

  11. Volm M, Samsel B, Mattern J (1990) Relationship between chemoresistance of lung tumours and cigarette smoking. Br J Cancer 62(2):255–256

    PubMed  CAS  Google Scholar 

  12. Baser S, Shannon VR, Eapen GA et al (2006) Smoking cessation after diagnosis of lung cancer is associated with a beneficial effect on performance status. Chest 130(6):1784–1790. doi:10.1378/chest.130.6.1784

    Article  PubMed  Google Scholar 

  13. Gritz ER, Fingeret MC, Vidrine DJ, Lazev AB, Mehta NV, Reece GP (2006) Successes and failures of the teachable moment: smoking cessation in cancer patients. Cancer 106(1):17–27. doi:10.1002/cncr.21598

    Article  PubMed  Google Scholar 

  14. de Moor JS, Puleo E, Butterfield RM, Li FP, Emmons KM (2007) Availability of smoking prevention and cessation services for childhood cancer survivors. Cancer Causes Control 18(4):423–430. doi:10.1007/s10552-006-0110-y

    Article  PubMed  Google Scholar 

  15. Stull VB, Snyder DC, Demark-Wahnefried W (2007) Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr 137(1 Suppl):243S–248S

    PubMed  CAS  Google Scholar 

  16. Klosky JL, Tyc VL, Garces-Webb DM, Buscemi J, Klesges RC, Hudson MM (2007) Emerging issues in smoking among adolescent and adult cancer survivors: a comprehensive review. Cancer 110(11):2408–2419. doi:10.1002/cncr.23061

    Article  PubMed  Google Scholar 

  17. Lerman C, Schnoll RA, Patterson F (in press) Nicotine dependence: current treatments and future directions. In: Abeloff M (ed) Clinical oncology, 4th edn. Elsevier, Philadelphia

  18. Khantzian EJ (1997) The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry 4(5):231–244. doi:10.3109/10673229709030550

    Article  PubMed  CAS  Google Scholar 

  19. Schnoll RA, Malstrom M, James C et al (2002) Correlates of tobacco use among smokers and recent quitters diagnosed with cancer. Patient Educ Couns 46(2):137–145. doi:10.1016/S0738-3991(01)00157-4

    Article  PubMed  Google Scholar 

  20. Schnoll RA, Rothman RL, Newman H et al (2004) Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Psychooncology 13(5):346–358. doi:10.1002/pon.756

    Article  PubMed  Google Scholar 

  21. Sheehan DV, Lecrubier Y, Sheehan KH, et al. (1998) The mini-international neuropsychiatric interview (M.I·N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 59 (Suppl 20):22–33; quiz 4–57

    Google Scholar 

  22. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO (1991) The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom tolerance questionnaire. Br J Addict 86(9):1119–1127. doi:10.1111/j.1360-0443.1991.tb01879.x

    Article  PubMed  CAS  Google Scholar 

  23. Horn D, Waingrow S (1966) Behavior and attitudes questionnaire. National Clearinghouse for Smoking and Health, Bethesda, MD

    Google Scholar 

  24. Lerman C, Audrain J, Orleans CT, Boyd R, Gold K, Main D, Caporaso N (1996) Investigation of mechanisms linking depressed mood to nicotine dependence. Addict Behav 21:9–19. doi:10.1016/0306-4603(95)00032-1

    Article  PubMed  CAS  Google Scholar 

  25. Lerman C, Caporaso N, Main D, Audrain J, Boyd NR, Bowman ED, Shields PG (1998) Depression and self-medication with nicotine: the modifying influence of the dopamine D4 receptor gene. Health Psychol 17:56–62. doi:10.1037/0278-6133.17.1.56

    Article  PubMed  CAS  Google Scholar 

  26. Ray R, Rukstalis M, Jepson C, Strasser AA, Patterson F, Lynch K, Lerman C (2008) Effects of atomoxetine on subjective and neurocognitive symptoms of nicotine abstinence. J Psychopharmacol (Epub ahead of print)

  27. Radloff L (1977) The CES-D scale: a new self-report depression scale for research in the general population. Appl Psychol Meas 1:385–401. doi:10.1177/014662167700100306

    Article  Google Scholar 

  28. de Graeff A, de Leeuw JR, Ros WJ, Hordijk GJ, Blijham GH, Winnubst JA (2000) Pretreatment factors predicting quality of life after treatment for head and neck cancer. Head Neck 22(4):398–407. doi:10.1002/1097-0347(200007)22:4&lt;398::AID-HED14&gt;3.0.CO;2-V

    Article  PubMed  Google Scholar 

  29. Watson D, Clark LA, Tellegen A (1988) Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol 54(6):1063–1070. doi:10.1037/0022-3514.54.6.1063

    Article  PubMed  CAS  Google Scholar 

  30. Miller WR, Rollnick S (2002) Motivational interviewing: preparing people for change. Guilford Press, New York

    Google Scholar 

  31. Williams EC, Horton NJ, Samet JH, Saitz R (2007) Do brief measures of readiness to change predict f consumption and consequences in primary care patients with unhealthy alcohol use? Alcohol Clin Exp Res 31(3):428–435. doi:10.1111/j.1530-0277.2006.00324.x

    Article  PubMed  Google Scholar 

  32. Baquet CR, Commiskey P, Daniel Mullins C, Mishra SI (2006) Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors. Cancer Detect Prev 30(1):24–33. doi:10.1016/j.cdp.2005.12.001

    Article  PubMed  Google Scholar 

  33. Ferguson JA, Patten CA, Schroeder DR, Offord KP, Eberman KM, Hurt RD (2003) Predictors of 6-month tobacco abstinence among 1224 cigarette smokers treated for nicotine dependence. Addict Behav 28(7):1203–1218. doi:10.1016/S0306-4603(02)00260-5

    Article  PubMed  Google Scholar 

  34. Shiffman S, Paty JA, Gnys M, Kassel JA, Hickcox M (1996) First lapses to smoking: within-subjects analysis of real-time reports. J Consult Clin Psychol 64(2):366–379. doi:10.1037/0022-006X.64.2.366

    Article  PubMed  CAS  Google Scholar 

  35. Niaura R, Britt DM, Shadel WG, Goldstein M, Abrams D, Brown R (2001) Symptoms of depression and survival experience among three samples of smokers trying to quit. Psychol Addict Behav 15(1):13–17. doi:10.1037/0893-164X.15.1.13

    Article  PubMed  CAS  Google Scholar 

  36. Velicer WF, Prochaska JO, Rossi JS, Snow MG (1992) Assessing outcome in smoking cessation studies. Psychol Bull 111:23–41. doi:10.1037/0033-2909.111.1.23

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

The authors would like to thank Dr. Eric Sherman, Holly Pedri, Christine Kopistansky, Dustin Wielt, Marcella Glass, Dr. Peter Gariti, and Jeanne Pomenti for assisting with the implementation of this research project and/or manuscript preparation. This study was funded by grant R01 CA95678 from the National Cancer Institute. All patients provided informed consent for this study.

Author information

Authors and Affiliations

  1. Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA

    Elisa Martinez, Kristina L. Tatum, Dorothy M. Weber, Natalie Kuzla, Anna Pendley, Kirsten Campbell, John A. Ridge & Corey Langer

  2. Department of Radiation Oncology, Temple University Hospital, 3401 N. Broad Street, Philadelphia, PA, 19140, USA

    Curtis Miyamoto

  3. Transdisciplinary Tobacco Use Research Center, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, 4th Floor, Philadelphia, PA, 19104, USA

    Robert A. Schnoll

Authors
  1. Elisa Martinez
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kristina L. Tatum
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Dorothy M. Weber
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Natalie Kuzla
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Anna Pendley
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Kirsten Campbell
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. John A. Ridge
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Corey Langer
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Curtis Miyamoto
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Robert A. Schnoll
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Elisa Martinez.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Martinez, E., Tatum, K.L., Weber, D.M. et al. Issues related to implementing a smoking cessation clinical trial for cancer patients. Cancer Causes Control 20, 97–104 (2009). https://doi.org/10.1007/s10552-008-9222-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10552-008-9222-x

Keywords

Search

Navigation