Quit2Heal: Rigorous Randomized Trial of a Smartphone Application to Help Cancer Patients Stop Smoking

项目总结/摘要（描述） 在美国，15%至54%的癌症患者在诊断时吸烟。不幸的是， 高达80%的癌症患者在确诊后仍继续吸烟。癌症后持续吸烟 诊断导致更差的临床结果，包括治疗有效性降低， 疾病复发、发展为第二种癌症的风险增加以及死亡率更高。国家 综合癌症网络（NCCN）建议为每一位吸烟的癌症患者提供一个 循证戒烟干预。然而，获得有效戒烟干预措施的机会有限， 这是在癌症护理背景下促进戒烟的关键障碍。现在需要的是一种方法，所有吸烟者 获得有效和低成本的干预措施，旨在帮助这一特殊人群停止 smoking.智能手机应用程序（“app”）可以通过提供广泛可用的 针对癌症患者的烟草干预。应用程序具有潜在的高人群水平，可达到癌症 特别是考虑到超过四分之三（76%）的吸烟者拥有智能手机。尽管他们的高 潜在的价值，没有证据表明：（1）针对癌症的智能手机应用程序的有效性 吸烟的患者和（2）为什么这些应用程序会有效。同样未被探索的是谁最有可能受益 针对吸烟癌症患者的智能手机应用程序。我们最近开发了第一个已知的 这款名为“Quit 2 Heal”的智能手机应用程序专门用于帮助癌症患者戒烟。我们比较 Quit 2 Heal与NCI的QuitGuide，一个广泛使用的戒烟应用程序，为一般人群，在试点 随机对照试验，59名吸烟的成年癌症患者。两个月后保持率为92%- 向上，Quit 2 Heal的30天时点戒烟率为20%，QuitGuide为7%（OR=5.16; 95%CI：0.71， 37.29; p=.104）。在这些知识差距和令人鼓舞的结果的基础上，本申请建议 进行一项Quit 2 Heal（n = 211）与QuitGuide（n = 211）的全把握度随机对照试验， 确定：（1）Quit 2 Heal是否具有显著更高的生化验证的30天点患病率 与QuitGuide相比，随机化后12个月时戒烟，以及（2）Quit 2 Heal（但不 QuitGuide的）12个月的戒烟结果是由癌症的改善显着介导的- 相关的羞耻，耻辱，抑郁，焦虑，以及对吸烟与戒烟后后果的了解 癌症诊断该项目还将探讨这些基线因素是否会缓和停止 结果：（a）癌症类型，（B）癌症分期，（c）自诊断以来的时间，（d）人口统计学，（e） 伴侣/配偶吸烟，（f）肿瘤学家是否建议参与者戒烟，以及（g）招募 源头如果目标得以实现，该项目将推进有关应用程序有效性的科学知识 帮助癌症患者戒烟。积极的结果将提供一个有效和高度可及的 对癌症患者的公共卫生干预。

PROJECT SUMMARY/ABSTRACT (DESCRIPTION) In the US, 15% to 54% of cancer patients are cigarette smokers at the time of their diagnosis. Unfortunately, up to 80% of smokers with cancer continue to smoke after their diagnosis. Persistent smoking after a cancer diagnosis leads to worse clinical outcomes including decreased treatment effectiveness, increased risk of disease recurrence, increased risk of developing second cancers, and higher mortality rates. The National Comprehensive Cancer Network (NCCN) recommends that every cancer patient who smokes be offered an evidence-based cessation intervention. However, limited access to effective tobacco cessation interventions is a key barrier for promoting cessation in the context of cancer care. Needed now is a method for all smokers with cancer to access effective and low-cost interventions designed to help this special population stop smoking. A smartphone application (“app”) could address the access need by providing a widely available tobacco intervention targeted for cancer patients. Apps have potentially high population level reach to cancer patients—especially given that over three quarters (76%) of all smokers own smartphones. Despite their high potential value, there is no evidence about: (1) the effectiveness of smartphone apps targeted to cancer patients who smoke and (2) why these apps would be effective. Also unexplored is who is most likely to benefit from smartphone apps targeted to cancer patients who smoke. We recently developed the first known smartphone app (called “Quit2Heal”) specifically designed to help cancer patients quit smoking. We compared Quit2Heal with the NCI’s QuitGuide, a widely used smoking cessation app for the general population, in a pilot randomized controlled trial with 59 adult cancer patients who smoke. With 92% retention at the 2-month follow- up, 30-day point prevalence quit rate was 20% for Quit2Heal vs. 7% for QuitGuide (OR=5.16; 95% CI: .71, 37.29; p=.104). Building on these knowledge gaps and encouraging results, this application proposes to conduct a fully powered randomized controlled trial of Quit2Heal (n = 211) versus QuitGuide (n = 211), in order to determine whether: (1) Quit2Heal has significantly higher biochemically verified 30-day point prevalence smoking cessation at 12 months post-randomization relative to QuitGuide, and (2) Quit2Heal’s (but not QuitGuide’s) 12-month smoking cessation outcome is significantly mediated by improvements in cancer- related shame, stigma, depression, anxiety, and knowledge about consequences of smoking vs. quitting after cancer diagnosis. The project will also explore whether these baseline factors moderate the cessation outcome: (a) cancer type, (b) stage of cancer, (c) time since diagnosis, (d) demographics, (e) having a partner/spouse who smokes, (f) whether participant was advised to quit by oncologist, and (g) recruitment source. If the aims are achieved, this project will advance scientific knowledge about the effectiveness of apps for helping cancer patients quit smoking. Positive results would provide an effective and highly accessible public health intervention for cancer patients.