Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
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.


Options:
A: Arm Label: High reinforcement cessation program; Type: EXPERIMENTAL; Interventions: Behavioral: high reinforcement cessation program | Arm Label: Low reinforcement cessation program; Type: EXPERIMENTAL; Interventions: Behavioral: low reinforcement cessation program | Intervention Type: BEHAVIORAL; Name: high reinforcement cessation program; Assigned to Arm(s): High reinforcement cessation program | Intervention Type: BEHAVIORAL; Name: low reinforcement cessation program; Assigned to Arm(s): Low reinforcement cessation program
B: Arm Label: 1; Type: N/A; Interventions: N/A | Arm Label: 2; Type: N/A; Interventions: N/A | Arm Label: 3; Type: N/A; Interventions: N/A | Arm Label: 4; Type: N/A; Interventions: N/A | Arm Label: 5; Type: N/A; Interventions: N/A | Arm Label: 6; Type: N/A; Interventions: N/A
C: Arm Label: PRO+NRT+TC; Type: EXPERIMENTAL; Interventions: Other: proactive outreach (PRO), Other: telephone counseling (TC), Other: Nicotine replacement therapy (NRT) | Arm Label: Usual Care (UC); Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care (UC) | Intervention Type: OTHER; Name: proactive outreach (PRO); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: telephone counseling (TC); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: Nicotine replacement therapy (NRT); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: Usual care (UC); Assigned to Arm(s): Usual Care (UC)
D: Arm Label: Standard Care (SC); Type: EXPERIMENTAL; Interventions: Behavioral: Standard Care (SC) | Arm Label: Intensive Counseling (IC); Type: EXPERIMENTAL; Interventions: Behavioral: Intensive Counseling (IC) | Intervention Type: BEHAVIORAL; Name: Standard Care (SC); Assigned to Arm(s): Standard Care (SC) | Intervention Type: BEHAVIORAL; Name: Intensive Counseling (IC); Assigned to Arm(s): Intensive Counseling (IC)

Answer: D