Smoke Free Support Study 2.0
Hematopoietic Malignancies
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
EAQ171CD (primary)
EAQ171CD
ECOG-ACRIN-EAQ171CD
NCI-2018-02826
Summary
This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.
Objectives
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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).
EXPLORATORY OBJECTIVES:
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 (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 (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.
Eligibility
- STAFF ELIGIBILITY CRITERIA: Must be English speaking
- STAFF ELIGIBILITY CRITERIA: Must be employed at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site for at least three months
- PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Age >= 18 years
- 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 ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days
- PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish
- PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must have telephone, web and electronic (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)
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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