Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices

ECOG-ACRIN Cancer Research Group306 enrolled

Overview

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.

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 the investigator's 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Conditions

Carcinoma In Situ Current Smoker Malignant Neoplasm Primary Neoplasm Recurrent Neoplasm Smoking Cessation

Interventions

Behavioral, Psychological or Informational InterventionOTHER

Receive information about tobacco cessation

Nicotine ReplacementDRUG

Given NRT patch or lozenge (or both)

Quality-of-Life AssessmentOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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: * 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, 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. * 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). Exclusion Criteria: * 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.

Locations (42)

Outcomes

Primary Outcomes

Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)

We will define 7-day point-prevalence by saliva cotinine (\< 15 ng/ml) or expired air CO (\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.

Time frame: At 6 months

Secondary Outcomes

Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)

We will define 7-day point-prevalence by saliva cotinine (\< 15 ng/ml) or expired air CO (\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. COVID-19 restrictions prevented any saliva or CO sample collection or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim.

Time frame: At 3 months

7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report

7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.

Time frame: At 6 months

7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report

Data from ClinicalTrials.gov

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