Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]

Brett M Goshe^{1

2

3

4}, Autumn W Rasmussen^{5

6

7}, Lynne I Wagner⁸, JoRean D Sicks⁹, Ilana F Gareen¹⁰, Ruth C Carlos¹¹, Benjamin A Herman⁹, Angela Wangari Walter^{7

12}, Susan Regan^{6

13}, Douglas E Levy^{6

13}, Irene Mahon¹⁴, Alona Muzikansky¹⁵, Jordan M Neil^{7

16}, Michelle Lui¹⁷, Deepika Dilip¹⁷, Laura Malloy⁷, Irina Gonzalez⁷, Lucy Finkelstein-Fox^{5

6

7

13}, Caitlin McCann⁷, Elissa Perez⁷, Jamie S Ostroff^#^{7

17}, Elyse R Park^#^{5

6

7

13}

Affiliations

¹ Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, USA. bgoshe@mgh.harvard.edu.
² Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston, MA, USA. bgoshe@mgh.harvard.edu.
³ Health Promotion and Resiliency Intervention Research Program, Massachusetts General Hospital, Boston, MA, USA. bgoshe@mgh.harvard.edu.
⁴ Harvard Medical School, Boston, MA, USA. bgoshe@mgh.harvard.edu.
⁵ Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, USA.
⁶ Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston, MA, USA.
⁷ Health Promotion and Resiliency Intervention Research Program, Massachusetts General Hospital, Boston, MA, USA.
⁸ Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁹ ECOG-ACRIN Biostatistics Center, Brown University, Providence, RI, USA.
¹⁰ Department of Epidemiology and the Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, USA.
¹¹ Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.
¹² Department of Public Health, Zuckerberg College of Health Sciences, University of Massachusetts Lowell, Lowell, MA, USA.
¹³ Harvard Medical School, Boston, MA, USA.
¹⁴ ECOG-ACRIN Cancer Research Group, American College of Radiology, Philadelphia, PA, USA.
¹⁵ Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
¹⁶ Department of Family and Preventative Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
¹⁷ Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

^# Contributed equally.

PMID: 35841024
PMCID: PMC9284951
DOI: 10.1186/s12889-022-13631-w

Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]

Brett M Goshe et al. BMC Public Health. 2022.

. 2022 Jul 15;22(1):1359.

doi: 10.1186/s12889-022-13631-w.

Authors

Affiliations

¹ Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, USA. bgoshe@mgh.harvard.edu.
² Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston, MA, USA. bgoshe@mgh.harvard.edu.
³ Health Promotion and Resiliency Intervention Research Program, Massachusetts General Hospital, Boston, MA, USA. bgoshe@mgh.harvard.edu.
⁴ Harvard Medical School, Boston, MA, USA. bgoshe@mgh.harvard.edu.
⁵ Department of Psychiatry, Massachusetts General Hospital / Harvard Medical School, 100 Cambridge Street, Suite 1600, Boston, MA, 02114, USA.
⁶ Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Boston, MA, USA.
⁷ Health Promotion and Resiliency Intervention Research Program, Massachusetts General Hospital, Boston, MA, USA.
⁸ Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁹ ECOG-ACRIN Biostatistics Center, Brown University, Providence, RI, USA.
¹⁰ Department of Epidemiology and the Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, USA.
¹¹ Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.
¹² Department of Public Health, Zuckerberg College of Health Sciences, University of Massachusetts Lowell, Lowell, MA, USA.
¹³ Harvard Medical School, Boston, MA, USA.
¹⁴ ECOG-ACRIN Cancer Research Group, American College of Radiology, Philadelphia, PA, USA.
¹⁵ Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
¹⁶ Department of Family and Preventative Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
¹⁷ Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

^# Contributed equally.

PMID: 35841024
PMCID: PMC9284951
DOI: 10.1186/s12889-022-13631-w

Abstract

Background: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings.

Methods/design: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes.

Discussion: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery.

Trial registration: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

Keywords: Cancer Care; Implementing Tobacco Treatment; Motivational Interviewing; NCORP; Pharmacotherapy; Randomized Controlled Trial; Smoking Cessation; Tobacco Treatment.

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Conflict of interest statement

RC: Salary support from JACR as editor-in-chief, Travel reimbursement from ARBIR, ARRS, RSNA. JO: reports receiving royalties from UpToDate. EPa: UpToDate chapter editor. BG, AR, LW, JS, IG, BH, AWW, SR, DL, IM, AM, JN, ML, DD, LM, IG, LFF, CM, EPe declare that they have no competing interests.

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Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]

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Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]

Authors

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Conflict of interest statement

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