Department of Population Health, New York University School of Medicine, New York, NY, United States.
Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, United States.
JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10071. doi: 10.2196/10071.
Although smoking cessation apps have become popular, few have been tested in randomized clinical trials or undergone formative evaluation with target users.
We developed a cessation app targeting tobacco-dependent cancer patients. Game design and behavioral rehearsal principles were incorporated to help smokers identify, model, and practice coping strategies to avoid relapse to smoking. In this randomized pilot trial, we examined feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence, and other cessation-related indices to guide the development of a larger trial.
We randomized 42 English-speaking cancer patients scheduled for surgical treatment to either the Standard Care (SC; telecounseling and cessation pharmacotherapies) or the experimental QuitIT study arm (SC and QuitIT game). Gameplay parameters were captured in-game; satisfaction with the game was assessed at 1-month follow-up. We report study screening, exclusion, and refusal reasons; compare refusal and attrition by key demographic and clinical variables; and report tobacco-related outcomes.
Follow-up data were collected from 65% (13/20) patients in the QuitIT and 61% (11/18) in SC arms. Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people. Most had either lung (12/38, 32%) or gastrointestinal (9/38, 24%) cancer. Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05). Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data). There were no differences between those who played and did not play by demographic, clinical, technology use, and tobacco-related variables. Users completed an average of 2.5 (SD 4.0) episodes out of 10. A nonsignificant trend was found for increased confidence to quit in the QuitIT arm (d=0.25, 95% CI -0.56 to 1.06), and more participants were abstinent in the QuitIT group than in the SC arm (4/13, 30%, vs 2/11, 18%). Satisfaction with gameplay was largely positive, with most respondents enjoying use, relating to the characters, and endorsing that gameplay helped them cope with actual smoking urges.
Recruitment and retention difficulties suggest that the perihospitalization period may be a less than ideal time for delivering a smoking cessation app intervention. Framing of the app as a "game" may have decreased receptivity as participants may have been preoccupied with hospitalization demands and illness concerns. Less tablet experience and older age were associated with participant dropout. Although satisfaction with the gameplay was high, 60% (12/20) of QuitIT participants did not play the game. Paying more attention to patient engagement, changing the intervention delivery period, providing additional reward and support for use, and improving cessation app training may bolster feasibility for a larger trial.
ClinicalTrials.gov NCT01915836; https://clinicaltrials.gov/ct2/show/NCT01915836 (Archived by WebCite at http://www.webcitation.org/73vGsjG0Y).
尽管戒烟应用程序已经很流行，但很少有程序经过随机临床试验测试或经过目标用户的形成性评估。
我们开发了一款针对烟草依赖癌症患者的戒烟应用程序。游戏设计和行为排练原则被纳入其中，以帮助吸烟者识别、模拟和练习应对策略，避免复吸。在这项随机试点试验中，我们检查了可行性（招募和保留率）、可接受性（患者满意度）、戒烟自信和其他与戒烟相关的指标，以指导更大规模试验的开展。
我们将 42 名计划接受手术治疗的英语癌症患者随机分配到标准护理（SC；电话咨询和戒烟药物治疗）或实验性 QuitIT 研究臂（SC 和 QuitIT 游戏）。游戏玩法参数在游戏中捕获；在 1 个月的随访中评估对游戏的满意度。我们报告研究筛选、排除和拒绝的原因；按关键人口统计学和临床变量比较拒绝和失访率；并报告与烟草相关的结果。
从 QuitIT 组的 20 名患者（65%，13/20）和 SC 组的 18 名患者（61%，11/18）中收集了随访数据。入组患者中 71%（27/38）为女性，92%（35/38）为白人，95%（36/38）为非西班牙裔。大多数人患有肺癌（12/38，32%）或胃肠道癌（9/38，24%）。那些退出的人比完成者更不可能使用平板电脑（P<.01），也更不可能玩过游戏（P=.02），并且更可能年龄较大（P=.05）。在 QuitIT 组的 20 名患者中，40%（8/20）玩过游戏（系统数据）。玩游戏和不玩游戏的患者在人口统计学、临床、技术使用和与烟草相关的变量方面没有差异。用户平均完成了 10 个情节中的 2.5 个（SD 4.0）。在 QuitIT 臂中，戒烟信心增加的趋势不显著（d=0.25，95%置信区间-0.56 至 1.06），并且 QuitIT 组的戒烟者比例高于 SC 组（4/13，30%，vs 2/11，18%）。对游戏玩法的满意度基本为正面，大多数受访者喜欢使用、与角色产生共鸣，并认可游戏玩法有助于他们应对实际的吸烟冲动。
招募和保留方面的困难表明，围手术期可能不是提供戒烟应用程序干预的理想时期。将应用程序定位为“游戏”可能会降低接受度，因为参与者可能会专注于住院需求和疾病担忧。较少的平板电脑使用经验和年龄较大与参与者失访有关。尽管对游戏玩法的满意度较高，但 60%（12/20）的 QuitIT 参与者没有玩游戏。更多关注患者参与度、改变干预交付期、为使用提供额外奖励和支持以及改进戒烟应用程序培训，可能会提高更大规模试验的可行性。
ClinicalTrials.gov NCT01915836；https://clinicaltrials.gov/ct2/show/NCT01915836（由 WebCite 存档；http://www.webcitation.org/73vGsjG0Y）。
