Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 42
- 主要终点
- Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
Arm A (smoking assessment, quitting advice, Quitline referral)
Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.
干预措施: Behavioral, Psychological or Informational Intervention (Other)
Arm A (smoking assessment, quitting advice, Quitline referral)
Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.
干预措施: Quality-of-Life Assessment (Other)
Arm B (virtual counseling sessions, NRT)
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 NRT (patch and lozenge combined or alone).
干预措施: Nicotine Replacement (Drug)
Arm B (virtual counseling sessions, NRT)
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 NRT (patch and lozenge combined or alone).
干预措施: Quality-of-Life Assessment (Other)
Arm B (virtual counseling sessions, NRT)
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 NRT (patch and lozenge combined or alone).
干预措施: Survey Administration (Other)
Arm B (virtual counseling sessions, NRT)
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 NRT (patch and lozenge combined or alone).
干预措施: Tobacco Cessation Counseling (Other)
结局指标
主要结局
Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
时间窗: At 6 months
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.
次要结局
- Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)(At 3 months)
- 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report(At 6 months)
- 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report(At 3 months)
- Self-reported Continuous Tobacco Abstinence(At 3months and 6 months)
- Sustained Tobacco Abstinence at 6 Months (Not Evaluated)(At 6 months)
- Significant Reduction in Smoking(baseline and 6 months)
- Significant Reduction in Smoking @ 3 Months(baseline and 3 months)