Smoke Free Support Study 2.0
- STAFF ELIGIBILITY CRITERIA:
- Must be English speaking.
- Must be employed at NCI Community Oncology Research Program (NCORP) site for at least three months.
- PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1:
- Patient presenting with any type of cancer with a date of diagnosis within the past 4 months. Recurrence, diagnosed within the last 4 months, of tumors in patients with past cancer diagnoses will be considered eligible. Patients with a new primary cancer, diagnosed within the last 4 months, who have been treated previously for other types of cancer will also be considered eligible. “In situ” cancers, diagnosed within the past 4 months, will also be considered eligible.
- Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days.
- Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish.
- Patient must have telephone, web and e-mail access and have access to the internet with a camera-enabled device (e.g.,. smartphone, tablet, computer, laptop with a webcam/camera). * NOTE: The restriction to those with web and e-mail access is based on the primary intention of the study; to assess the implementation of the virtual intervention in the NCORP network.
- ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0. * The requirement to register within 4 months from cancer diagnosis is determined by the date of the step 0 registration and not the date of the step 1 registration
- ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1).
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above, or is deemed medically unable to participate by study investigators or oncology clinician (i.e., referral to hospice).
- Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site.
I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.
I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.
II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.
III. Significant reduction (> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.
IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).
I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.
II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of our intervention at community oncology sites.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (Enhanced Usual Care [EUC]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.
ARM B (Virtual Intervention Treatment [VIT]): Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge combined or alone).
After completion of study, patients may be followed up for 1 year.
Trial Phase Phase II
Trial Type Health services research
ECOG-ACRIN Cancer Research Group
- Primary ID EAQ171CD
- Secondary IDs NCI-2018-02826, ECOG-ACRIN-EAQ171CD
- Clinicaltrials.gov ID NCT03808818