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Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial
Open accessAbstract
Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.
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“Additionally, counselors review a randomly selected, previously recorded counseling session and rate adherence to the treatment protocol and MI principles, using the treatment fidelity checklist [30, 41].”
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InfluentialGittleman, J., Cloutier, J. G., Park, E. R., Rasmussen, A. W., Ponzani, C. J., Weinberger, A. H., Ostroff, J. S., & Perez, G. K. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-09030-z · Cited by 3
“Additional entry criteria are described by Park and colleagues [16].”
InfluentialSelf-citationStreck, J. M., Hyland, K. A., Regan, S., Muzikansky, A., Rigotti, N. A., Ponzani, C. J., Perez, G. K., Kalkhoran, S. M., Ostroff, J. S., & Park, E. R. (2020) · Addictive Behaviors · doi:10.1016/j.addbeh.2020.106794 · Cited by 3
Self-citationDeterminants of persistent smoking among breast cancer survivors
Gali, K., Aryal, S., Bokemeyer, F., Behrens, S., Seibold, P., Obi, N., Becher, H., & Chang-Claude, J. C. (2024) · Preventive Medicine Reports · doi:10.1016/j.pmedr.2024.102913 · Cited by 2
Johnson, A. L., Avila, J. C., Christensen, L., Fahey, M. C., Jang, J., Jarvis, S., Rojewski, A. M., Rubenstein, D., & Kleykamp, B. A. (2025) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntaf122 · Cited by 2
Vinson, M., Tegge, A. N., Tokala, M. R., Spivey, C., Tenzer, M. M., Stein, J. S., Epling, J. W., & Rockwell, M. S. (2025) · PLoS ONE · doi:10.1371/journal.pone.0323582 · Cited by 2
Presant, C. A., Till, C., Vaidya, R., Ashing, K. T., Warren, G. W., Sun, V. C.-Y., Salgia, R., Massarelli, E., Mortimer, J. E., Pal, S. K., et al. (2024) · Cancer · doi:10.1002/cncr.35560 · Cited by 2
Metastatic colon cancer: clinical practice guideline update in 2024
Fedyanin, M. Y., Gladkov, O. A., Gordeyev, S. S., Карачун, А. М., Козлов, Н. А., Mamedli, Z. Z., Rykov, I. V., Tryakin, A. A., Цуканов, А. С., & Черных, М. В. (2024) · Surgery and Oncology · doi:10.17650/2949-5857-2024-14-4-31-42 · Cited by 2
Novel Survivorship Paradigms in Head/Neck Cancer
Armache, M., Larson, A., Stemme, R., Walsh‐Bailey, C., Scott, K., Pearman, T. P., Stepan, K. O., Mierzwa, M. L., Mady, L. J., & Gharzai, L. A. (2025) · Seminars in Radiation Oncology · doi:10.1016/j.semradonc.2025.02.003 · Cited by 2
Hoogland, C. E., Sutton, S. K., Fennell, B. S., Simmons, V. N., Vinci, C., Naqa, I. E., Salloum, R. G., Shete, S. S., Hembree, T. N., Vidrine, D. J., et al. (2025) · AJPM Focus · doi:10.1016/j.focus.2025.100361 · Cited by 2
“7,8 This study team led one of these trials, and the intervention group, motivation and problem solving (MAPS), allowed participants — women with a history of CIN or cervical cancer — to schedule 6 MAPS telephone counseling sessions over a period of up to 12 months, on the basis of treat-ment needs…”
Streck, J. M., Walter, A. W., Temel, J. S., El-Jawahri, A. R., Shin, H. J., Regan, S., Muzikansky, A., Ponzani, C. J., Ostroff, J. S., & Park, E. R. (2022) · Supportive Care in Cancer · doi:10.1007/s00520-021-06688-7 · Cited by 2
Self-citationBetter Together: Advancing Tobacco Use Treatment and Lung Cancer Screening
Shoenbill, K. A., & Goldstein, A. O. (2024) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2024.01.011 · Cited by 2
Bricker, J. B., Westmaas, J. L., Ostroff, J. S., Mull, K. E., Sullivan, B. M., & Santiago-Torres, M. (2023) · Contemporary Clinical Trials · doi:10.1016/j.cct.2023.107180 · Cited by 2
Self-citationTabakentwöhnung – eine der effektivsten medizinischen Maßnahmen
Raspe, M., Lo, K., Sommer, N., & Andreas, S. (2024) · Zeitschrift für Pneumologie · doi:10.1007/s10405-024-00555-y · Cited by 1
Santiago‐Torres, M. (2025) · American Journal of Cancer Research · doi:10.62347/spvk4847 · Cited by 1
Systematic Review for the Follow-up of Curatively Treated Patients With Lung Cancer
Shargall, Y., Vella, E. T., Giudice, M. E. D., Dennie, C. J., Ellis, P. M., Kulkarni, S., MacRae, R. M., & Ung, Y. C. (2025) · Clinical Lung Cancer · doi:10.1016/j.cllc.2025.03.003 · Cited by 1
DeVuono, I. R., Posa, S., Lafond, N. M. C., Woodley, B. D., Coroiu, A., Chaiton, M., Evans, W. K., Veldhuizen, S., Zawertailo, L. A., Melamed, O. C., et al. (2025) · Cancer Control · doi:10.1177/10732748251359835 · Cited by 2
Motivation for Smoking Cessation in Patients With Oral Squamous Cell Carcinoma—A One‐Time Survey
Gruber, L. J., Bühler, M. M., Spillner, A., Andreas, S., Kauffmann, P., Schliephake, H., & Wolfer, S. (2025) · Clinical and Experimental Dental Research · doi:10.1002/cre2.70154 · Cited by 1
Lemos, V. S., Colombo, T. E., Saleh, M., Guilherme, N. T., Bauleo, L. A., Silva, P. R., Farina, P. H. C., Nascimento, A. M. T., Manoel, L. H., & Fares, A. F. (2026) · Cancer Medicine · doi:10.1002/cam4.71718 · Cited by 1
Smoking cessation after a cancer diagnosis: Commentary on special supplement in Cancer Epidemiology
Smith, J., Togawa, K., Dresler, C. M., Hawari, F. I., Zain, Z. M., Stewart, B. W., Warren, G. W., & Sitas, F. (2022) · Cancer Epidemiology · doi:10.1016/j.canep.2022.102210 · Cited by 2
Gaikwad, R. N., Alqifari, F., Alnasser, M., Bajad, P., Jain, P., & Gondivkar, S. M. (2023) · PubMed Central · Cited by 1
Residential Treatment Exclusively for Tobacco Use Disorder: A Narrative Review
Spoelstra, S. K., van de Graaf, R. C., & Dijkstra, A. (2023) · Journal of Addiction Medicine · doi:10.1097/adm.0000000000001234 · Cited by 1
Pengaruh Merokok terhadap Performa dan Kesehatan Atlet
Kurbana, A. W., Qori’aina, L., Karim, M. A., & Marsha, S. (2024) · Pubmedia Jurnal Pendidikan Olahraga · doi:10.47134/jpo.v1i2.277 · Cited by 1
“Asap rokok mengandung berbagai zat beracun yang dapat merusak sel-sel pertahanan tubuh, melemahkan sistem kekebalan, dan membuat atlet lebih rentan terhadap infeksi dan penyakit (Courtney, 2021; Elisia, 2020; Park, 2020; Qasim, 2019; Redfors, 2020; Tetik, 2021).”
BackgroundFree Flap Enhanced Recovery Protocols in Head and Neck Surgery
Balaguru, L., Chow, L., Mifsud, M. J., Feng, A. L., Richmon, J. D., Lobaina, D., Old, M. O., Kakarala, K., Conrad, D. J., & Dziegielewski, P. T. (2024) · Facial Plastic Surgery Clinics of North America · doi:10.1016/j.fsc.2024.07.003 · Cited by 1
Masetti, V., Hadj-Henni, L., Rouger, G., Bacha, M. B., & Kechid, L. (2021) · L Encéphale · doi:10.1016/j.encep.2021.02.021
Cost-free pharmacotherapy in smokers with TIA or stroke: QUIT-MED randomised controlled trial
Reid, R. D., Papadakis, S., Gocan, S., Bourgoin, A., Laplante, M. A., Armstrong, A., Aitken, D., Sahlas, D. J., Stotts, G., Cotie, L. M., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-050403
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Tabakentwöhnung – eine der effektivsten medizinischen Maßnahmen
Raspe, M., Lo, K., Sommer, N., & Andreas, S. (2024) · Die Innere Medizin · doi:10.1007/s00108-024-01683-6
Dhumal, T., Kelly, K. M., Khadka, S., Kelley, G. A., Kamal, K. M., Scott, V., Hogan, T. F., & Harper, F. W. K. (2024) · Annals of Behavioral Medicine · doi:10.1093/abm/kaae040
Smith, N., Park, E. R., & Levy, D. E. (2025) · Cancer Causes & Control · doi:10.1007/s10552-025-01976-7
“Our tool is focused on the Smokefree Support Study intervention, an evidence-based smoking cessation program for patients recently in cancer care [17].”
InfluentialSelf-citationBokemeyer, F., Springorum, J., Lebherz, L., Bokemeyer, C., Schulz, H., Gali, K., Bleich, C., Kiefer, P., Püffel, S., & Freitag, J. (2025) · Tobacco Use Insights · doi:10.1177/1179173x251355531
“12,41 Likewise, the in fl uence of the social environment (C3.”
InfluentialThe Harms of Vaping: How Clinicians Can Help Patients Quit
Gonzalez, I. (2025) · Archivos de Bronconeumología · doi:10.1016/j.arbres.2025.09.001
Self-citationPerry, M., & Srivastava, S. B. (2025) · American Journal of Lifestyle Medicine · doi:10.1177/15598276251381627
Tobacco Dependence Treatment and Lung Cancer Control
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“Tobacco cessation interventions for cancer patients are associated with signi fi cant reduction in tobacco use (D ’ Angelo et al., 2020; Park et al., 2020) and are considered the standard of care (Shields et al., 2023).”
Webster, M. A., Burris, J. L., Cipri, C. S., Bird, J. E., Hayes, R. B., Sheffer, C. E., Khanna, N., Lenhoff, K., Minion, M. M., & Tong, E. K. (2025) · Supportive Care in Cancer · doi:10.1007/s00520-025-10244-y
“In many settings, free NRT (FNRT) significantly increases tobacco treatment (TT) engagement [19, 20], including utilization of state quitlines [21–23].”
Reinhardt, C., Harden, M., Herrmann‐Lingen, C., Rittmeyer, A., & Andreas, S. (2022) · Figshare · doi:10.6084/m9.figshare.20168291
Reinhardt, C., Harden, M., Herrmann‐Lingen, C., Rittmeyer, A., & Andreas, S. (2022) · Figshare · doi:10.6084/m9.figshare.20168294
Comparison of Black and/or Hispanic Cancer Patients’ Experiences in Virtual Tobacco Treatment
Rosen, R. S., Park, E. R., Nicolosi, G., Ostroff, J. S., & Perez, G. K. (2026) · Journal of Racial and Ethnic Health Disparities · doi:10.1007/s40615-025-02826-7
Self-citation
Metadata
- Authors
- Park, E. R., Perez, G. K., Regan, S., Muzikansky, A., Levy, D. E., Temel, J. S., Rigotti, N. A., Pirl, W. F., Irwin, K. E., Partridge, A. H., Cooley, M. E., Friedman, E. R., Rabin, J., Ponzani, C., Hyland, K. A., Holland, S., Borderud, S., Sprunck, K., Kwon, D., Peterson, L., Miller-Sobel, J., Gonzalez, I., Whitlock, C. W., Malloy, L., de León-Sanchez, S., O’Brien, M., & Ostroff, J. S.
- Affiliations
- Harvard University (US)
- Massachusetts General Hospital (US)
- Moffitt Cancer Center (US)
- Memorial Sloan Kettering Cancer Center (US)
- Dana-Farber Cancer Institute (US)
- Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, New York
- Corresponding author
- Park, Elyse R.
- ORCID
- Park, Elyse R.
- Perez, Giselle K.
- Regan, Susan
- Muzikansky, Alona
- Levy, Douglas E.
- Temel, Jennifer S.
- Rigotti, Nancy A.
- Pirl, William F.
- Irwin, Kelly E.
- Partridge, Ann H.
- Cooley, Mary E.
- Friedman, Emily R.
- Rabin, Julia
- Hyland, Kelly A.
- Holland, Susan
- Borderud, Sarah
- Kwon, Diana
- Gonzalez, Irina
- Malloy, Laura
- Ostroff, Jamie S.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-10-13
- Volume
- 324
- Issue
- 14
- Pages
- 1406
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8094414
- OpenAlex
- W3092359548
- Cited by
- 114
- References
- 40
- Citations by year
- 2026: 17 · 2025: 18 · 2024: 17 · 2023: 18 · 2022: 31 · 2021: 11 · 2020: 2
- FWCI
- 9.29
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- National Institutes of Health (UL1TR002384)
- National Cancer Institute (K24CA197382, R01CA166147, K08CA230185, P30CA008748)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- smoking cessation, cancer patients, telephone counseling, nicotine replacement therapy, bupropion, varenicline, smoking abstinence, treatment utilization, Spanish-speaking patients, breast cancer, lung cancer, head and neck cancer, gastrointestinal cancer, lymphoma, melanoma, genitourinary cancer, gynecologic cancer
- MeSH terms
- Varenicline, Smoking Cessation Agents, Aged, Cotinine, Counseling, Decision Support Techniques, Female, Humans, Male, Middle Aged, Neoplasms, Saliva, Smoking, Telephone, Temperance, Smoking Cessation, Bupropion, Patient Satisfaction, Patient Selection, Tobacco Use Cessation Devices, Motivational Interviewing
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