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

项目摘要/摘要(说明) 在美国，15%至54%的癌症患者在确诊时吸烟。不幸的是， 高达80%的癌症吸烟者在确诊后仍继续吸烟。癌症后持续吸烟 确诊会导致更糟糕的临床结果，包括治疗有效性降低，风险增加 疾病复发，罹患第二次癌症的风险增加，以及更高的死亡率。《国家报》 综合癌症网络(NCCN)建议为每一位吸烟的癌症患者提供 循证戒烟干预。然而，获得有效戒烟干预措施的机会有限 在癌症护理的背景下促进戒烟的一个关键障碍。现在需要的是一种适用于所有吸烟者的方法 与癌症患者一起获得有效和低成本的干预措施，旨在帮助这一特殊人群 抽烟。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口水平，可触及癌症 患者--尤其是考虑到超过四分之三(76%)的吸烟者拥有智能手机。尽管他们的高度 潜在价值，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 从针对吸烟的癌症患者的智能手机应用程序。我们最近开发出了第一个已知的 专门为帮助癌症患者戒烟而设计的智能手机应用程序(名为“Quit2Heal”)。我们比较了 Quit2Heal使用NCI的QuitGuide，这是一款广泛使用的普通人群戒烟应用程序，在试点中 59例成年癌症吸烟者的随机对照试验。在2个月内保留率为92%- Quit2Heal的30天戒烟率为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，该应用程序建议 按顺序进行Quit2Heal(n=211)与QuitGuide(n=211)的全功率随机对照试验 为了确定：(1)Quit2Heal是否具有显著更高的生化验证的30天点患病率 随机化后12个月戒烟与QuitGuide相关，(2)Quit2Heal(但不是 QuitGuide‘s)12个月的戒烟结果显著地受到癌症改善的影响- 相关羞耻、耻辱、抑郁、焦虑，以及吸烟与戒烟后果的知识 癌症诊断。该项目还将探索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)自确诊以来的时间，(D)人口统计数据，(E) 吸烟的伴侣/配偶，(F)肿瘤学家是否建议参与者戒烟，以及(G)招募 消息来源。如果这些目标得以实现，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。积极的结果将提供有效和高度可及的 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.