Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial

NCT01871506 | Completed Results DMC

• 2 other identifiers: 2013P0010361R01CA166147-01A1
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Documented risks associated with continued smoking following cancer diagnosis include decreased survival time; increased complications from surgery, radiation, and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health \& Human Services Public Health Service evidence-based tobacco treatment guidelines exist but have not been integrated into the cancer setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this treatment gap, the National Cancer Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and capacity for delivery of tobacco treatment in Cancer Centers. The American Society of Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by their second oncology visit as a core quality indicator; however, currently only half of patients report being asked about tobacco use. Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in suspected or newly diagnosed cancer patients. Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive Intensive Counseling (IC) or "Standard Care" (SC). Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm has the option to also receive:

• Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.
• Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months

  Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT

  6 months

Secondary Outcomes (9)

• Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months

  3 months

• Number of Participants With Continuous Tobacco Abstinence

  3 months to 6 months

• Number of Participants With Sustained Tobacco Abstinence

  6 months

• Number of Participants With Self-reported 7-day Point Prevalence.

  6 months

• The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy

  Treatment Initiation to 6 month follow-up

Study Arms (2)

Standard Care (SC)

EXPERIMENTAL

Participants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.

Behavioral: Standard Care (SC)

Intensive Counseling (IC)

EXPERIMENTAL

Participants randomized to intensive counseling (IC) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant.

Behavioral: Intensive Counseling (IC)

Interventions

Standard Care (SC) BEHAVIORAL

1. Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. 2. 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. 3. Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.

Also known as: "Standard of Care" Treatment

Standard Care (SC)

Intensive Counseling (IC) BEHAVIORAL

The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. 1. Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions. 2. Smoking cessation medication: IC participants will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline, bupropion or nicotine replacement therapy) of their choice, with the option to renew the medication twice for up to 90 days of free medication. Participants are not required to take smoking cessation medication.

Also known as: Intensive Treatment

Intensive Counseling (IC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women may participate in this study if he/she meet the following requirements:
• Current, new\* patient at one of our three participating study sites: Massachusetts General Hospital (MGH) Cancer Center, Memorial Sloan Kettering Cancer Center (MSKCC), or Dana-Farber Cancer Institute (DFCI);
• Currently with suspected or newly diagnosed cancer (thoracic, breast, genitourinary, gastrointestinal, head and neck, gynecologic, lymphoma, melanoma);
• Has smoked a cigarette, even a puff, in the past 30 days;
• Is willing to consider trying to quit smoking using counseling and/or smoking cessation medication;
• Is English or Spanish speaking (MGH); English speaking (MSK; DFCI);
• Has regular telephone access.
• \[\*Patients will be considered "new" and eligible under the following conditions:
• if they are attending approximately one of their first 4 visits or are within approximately 3 months of the initial visit date with their primary oncologist at the Massachusetts General Hospital (MGH) Cancer Center, Memorial Sloan Kettering Cancer Center (MSKCC), or Dana-Farber Cancer Institute (DFCI) for suspected or recently diagnosed cancer;
• if they come to the MGH, MSKCC, or DFCI for a second opinion, the patient opts to receive their cancer treatment at any of these institutions;
• if they have a past cancer diagnosis, they are currently faced with a local and distant recurrence of tumors;
• if they have been treated previously for other types of cancer, they are currently faced with a new form of cancer.\]

You may not qualify if:

• In an effort to be as inclusive as possible, a patient will be excluded only if he/she:
• Is NOT currently receiving or has no intentions to receive care at one of three participating cancer treatment centers: Massachusetts General Hospital Cancer Center, Memorial Sloan Kettering Cancer Center, or Dana-Farber Cancer Institute (DFCI);
• Is currently psychiatrically unstable or otherwise unable to provide informed consent as determined by study investigators or oncology clinician;
• Is not English or Spanish speaking;
• Is medically ineligible (as determined by their treating physician);
• Has insufficient comprehension/literacy.
• ADDITIONAL INFORMATION:
• Patients interested in participating in the study should contact the appropriate contact person, based on whether they are a current patient at the MGH, MSKCC, or DFCI.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (2)

• Park ER, Perez GK, Regan S, Muzikansky A, Levy DE, Temel JS, Rigotti NA, Pirl WF, Irwin KE, Partridge AH, Cooley ME, Friedman ER, Rabin J, Ponzani C, Hyland KA, Holland S, Borderud S, Sprunck K, Kwon D, Peterson L, Miller-Sobel J, Gonzalez I, Whitlock CW, Malloy L, de Leon-Sanchez S, O'Brien M, Ostroff JS. 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. JAMA. 2020 Oct 13;324(14):1406-1418. doi: 10.1001/jama.2020.14581.

  PMID: 33048154 DERIVED

• Park ER, Ostroff JS, Perez GK, Hyland KA, Rigotti NA, Borderud S, Regan S, Muzikansky A, Friedman ER, Levy DE, Holland S, Eusebio J, Peterson L, Rabin J, Miller-Sobel J, Gonzalez I, Malloy L, O'Brien M, de Leon-Sanchez S, Whitlock CW. Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial. Contemp Clin Trials. 2016 Sep;50:54-65. doi: 10.1016/j.cct.2016.07.016. Epub 2016 Jul 19.

  PMID: 27444428 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Associate Professor
• Organization: Elyse Park

epark@mgh.harvard.edu

617-724-6836

Study Officials

• Elyse R Park, Ph.D., MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jamie S. Ostroff, Ph.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)