Clinical trial NCT01871506: Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
Official title: Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2013-06-06
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Specific Aims

Aim 1: To compare the effectiveness of two tobacco treatments that are integrated into cancer care in producing tobacco abstinence at 6 months.

Aim 2: To explore: a) mechanisms through which treatment promotes abstinence; b) subpopulations in which abstinence is promoted; and c) which aspects of treatment promote abstinence.

Aim 3: To compare the incremental cost effectiveness (cost per quit) of two tobacco treatments.

Exploratory Aim: To identify the percentage and associated characteristics of smokers who 1) enroll in tobacco treatment and 2) adhere to tobacco treatment.

Eligibility criteria: INCLUSION CRITERIA:

Adult men and women may participate in this study if he/she meet the following requirements:

1. 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);
2. Currently with suspected or newly diagnosed cancer (thoracic, breast, genitourinary, gastrointestinal, head and neck, gynecologic, lymphoma, melanoma);
3. Has smoked a cigarette, even a puff, in the past 30 days;
4. Is willing to consider trying to quit smoking using counseling and/or smoking cessation medication;
5. Is English or Spanish speaking (MGH); English speaking (MSK; DFCI);
6. Has regular telephone access.

\[\*Patients will be considered "new" and eligible under the following conditions:

1. 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;
2. 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;
3. if they have a past cancer diagnosis, they are currently faced with a local and distant recurrence of tumors;
4. if they have been treated previously for other types of cancer, they are currently faced with a new form of cancer.\]

EXCLUSION CRITERIA:

In an effort to be as inclusive as possible, a patient will be excluded only if he/she:

1. 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);
2. Is currently psychiatrically unstable or otherwise unable to provide informed consent as determined by study investigators or oncology clinician;
3. Is not English or Spanish speaking;
4. Is medically ineligible (as determined by their treating physician);
5. Has insufficient comprehension/literacy.

ADDITIONAL INFORMATION:

Participant inclusion/exclusion is not based on use of smoking cessation medication -- he/she may decide not to use any smoking cessation medication and still participate in the study. Patients deemed ineligible will be referred to the state quit line.

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.

Primary outcomes:
measure: Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months
timeFrame: 3 months
measure: Number of Participants With Continuous Tobacco Abstinence
timeFrame: 3 months to 6 months
measure: Number of Participants With Sustained Tobacco Abstinence
timeFrame: 6 months
measure: Number of Participants With Self-reported 7-day Point Prevalence.
timeFrame: 6 months
measure: The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy
timeFrame: Treatment Initiation to 6 month follow-up
measure: The Number of IT Participants Who Used Smoking Cessation Counseling
timeFrame: Treatment Initiation to 6 Month Follow-up
measure: The Number of IT Participants Who Took 1-2 4-week Refills
timeFrame: Treatment Initiation to 6 Month Follow-up
measure: The Number of IT Participants Who Took 1-3 Monthly Booster Sessions
timeFrame: Treatment Initiation to 6 Month Follow-up
measure: Cost-effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Massachusetts General Hospital
name: Elyse R Park, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie S. Ostroff, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.