At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
In Brief
A clinical study evaluating Standard Care (SC) and Intensive Counseling (IC) for Smoking Cessation. Completed, enrolled 303 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.