Contingency Management to Promote Smoking Abstinence in Cancer Patients

促进癌症患者戒烟的应急管理

基本信息

批准号：
10027457
负责人：
Benjamin Andrew Toll
金额：
$ 53.73万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-07 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10027457
关键词：
Abstinence Adjuvant Advocate American Association of Cancer Research American Society of Clinical Oncology Behavior Therapy Biochemical Breath Tests Cancer Intervention Cancer Patient Carbon Monoxide Clinical Clinical Trials Counseling Data Day Surgery Diagnosis Effectiveness of Interventions Funding Health Incidence Infrastructure Intervention Intervention Studies Life Link Malignant Neoplasms Monitor National Comprehensive Cancer Network Operative Surgical Procedures Participant Patients Perioperative Pilot Projects Population Prevalence Protocols documentation Randomized Randomized Clinical Trials Recommendation Relapse Research Research Design Risk Second Primary Cancers Site Smoke Smoker Smoking Smoking Cessation Intervention Smoking Status Subgroup Surgical complication Testing Time Tobacco Use Cessation Tobacco use Toxic effect United States National Institutes of Health Work Wound Infection cancer care cancer diagnosis cancer site cancer surgery cancer therapy clinical care contingency management cost effective cost effectiveness design effective intervention effective therapy effectiveness evaluation financial incentive follow-up high risk improved medical complication mortality mortality risk nicotine replacement novel payment respiratory smoking abstinence smoking cessation smoking intervention standard care surgery outcome surgical risk tobacco abstinence tool treatment response wound healing

项目摘要

PROJECT SUMMARY There is a high incidence of tobacco use among patients with cancer. Many are unable to quit smoking before surgery, and relapse rates are high among those who are able to abstain after the initial cancer diagnosis. Tobacco use is linked to serious complications with treatment, including increased problems with wound healing after surgery. Contingency management, a behavioral intervention in which abstinence is reinforced (typically with monetary incentives), has shown promise as an intervention for smoking. In our preliminary work, we designed a contingency management protocol for pre-surgical cancer patients. A pilot study was conducted to generate an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery. Patients (N=40) were randomized to receive either: Standard Care + Monitoring (SC; i.e., 3-6 counseling sessions + nicotine replacement therapy [NRT] + monitoring breath CO 3 times per week with no contingencies; N=19) or CM (i.e., 3-6 counseling sessions + NRT + monetary payment delivered contingent on a negative breath CO; N=21). In the CM group 52% (11/21) of the patients were abstinent for 7 days prior to surgery compared to 16% (3/19) of the patients in SC (adjusted RR=3.3, CI: 1.1-9.7, p=0.03). At the 3-month follow-up, 43% (9/21) of CM patients remained abstinent compared to 5% (1/19) in the SC group (adjusted RR=8.6, CI: 1.5-49.4, p=0.02). For the present study, we propose a powered, large scale (N=282) smoking cessation clinical trial to test a CM intervention for cancer patients. The intervention will mirror our prior work, focusing on patients who are undergoing surgery for their cancer. No studies have evaluated a CM intervention with smokers who have a life-threatening illness. However, our pilot data with pre-surgical cancer patients who smoke has shown that this may be a promising intervention with cancer patients. We hypothesize that this highly effective treatment, by promoting high rates of smoking cessation, will also be associated with better surgical outcomes. Interventions for smoking cessation prior to cancer surgery are understudied and a valuable tool in promoting improved surgical outcomes.

项目概要癌症患者中吸烟的比例很高。许多人以前无法戒烟初次癌症诊断后能够戒烟的人的复发率很高。吸烟与治疗中的严重并发症有关，包括伤口问题增加手术后愈合。应急管理，一种加强禁欲的行为干预（通常有金钱奖励），已显示出作为吸烟干预措施的前景。在我们的初步在工作中，我们为术前癌症患者设计了应急管理方案。一项试点研究是旨在产生手术时戒烟的效应大小（7 天点患病率）禁欲），次要目标是确定术后 3 个月长期禁欲的效果大小。患者 (N=40) 被随机分配接受以下任一治疗：标准护理 + 监测 (SC；即 3-6 次咨询疗程 + 尼古丁替代疗法 [NRT] + 每周监测呼吸 CO 3 次，无意外事件； N=19）或 CM（即 3-6 次咨询课程 + NRT + 视情况支付金钱）呼吸负二氧化碳； N=21）。在 CM 组中，52% (11/21) 的患者在治疗前 7 天禁欲。相比之下，SC 患者的比例为 16% (3/19)（调整后 RR=3.3，CI：1.1-9.7，p=0.03）。 3个月时随访期间，43% (9/21) 的 CM 患者保持戒酒，而 SC 组只有 5% (1/19)（调整后） RR=8.6，CI：1.5-49.4，p=0.02）。对于本研究，我们提出了一种动力、大规模（N = 282）吸烟戒烟临床试验，测试对癌症患者的 CM 干预。这次干预将反映我们之前的工作，重点关注正在接受癌症手术的患者。没有研究评估 CM 干预患有危及生命疾病的吸烟者。然而，我们对术前癌症患者的试点数据烟雾表明这可能是对癌症患者的一种有希望的干预措施。我们假设这通过促进高戒烟率的高效治疗也将带来更好的效果。手术结果。癌症手术前的戒烟干预措施尚未得到充分研究，并且促进改善手术结果的宝贵工具。