Department of Medicine, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, 535 Barnhill Drive, Suite 473, Indianapolis, IN, 46202, USA.
Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA.
Qual Life Res. 2024 Dec;33(12):3401-3408. doi: 10.1007/s11136-024-03781-2. Epub 2024 Sep 4.
As cancer survivorship increases, there is a need for simple tools to measure and promote healthy behaviors. We created a wellness behavioral tool (the SMILE Scale) to encourage self-monitoring of wellness behaviors. This study aimed to determine the feasibility of collecting daily self-reported SMILE Scale data and weekly quality of life data among patients with cancer. We also aimed to measure the association between SMILE Scale responses and validated health-related quality of life (HRQOL) tools (PROMIS-29 + 2 and SymTrak-8) as a pilot test of the hypothesis that increased wellness behaviors may impact quality of life.
We surveyed 100 patients with cancer at the Indiana University Simon Comprehensive Cancer Center. Participants were asked to complete daily SMILE Scale assessments over a two-week period, as well as weekly PROMIS-29 + 2 and SymTrak-8 surveys. The primary endpoint was the SMILE Scale completion rate. Secondary endpoints in this single-arm pilot study included correlations between the SMILE Scale and other HRQOL tools.
Daily completion rate of the SMILE Scale ranged from 57% to 65% of participants over a 14-day period. Among the 61% of participants who completed SMILE on day 1, 87% completed SMILE on 10 of 14 days. By end of study, participants who self-reported more wellness behaviors (i.e., higher daily SMILE scores) demonstrated significantly higher PROMIS physical health (p = 0.003), higher PROMIS mental health (p = 0.008), and lower (better) SymTrak total symptom burden (p = 0.006). Further, among those who completed at least 1 of 14 daily SMILE assessments, quality of life significantly improved over the two-week period for PROMIS mental health (p = 0.018) and SymTrak total symptom burden (p = 0.014).
The SMILE Scale completion rate did not satisfy our pre-planned ≥70% threshold for feasibility; however, the rate for completing SMILE at least once during the 14 days (77%) met this threshold. Participants with higher average daily SMILE scores had significantly better scores across other validated HRQOL tools. While these results may be correlative and not causative, this suggests a potential physical and mental health benefit for delivering the SMILE Scale in clinical practice to help encourage healthy behaviors and warrants testing the SMILE Scale's impact in future studies.
随着癌症生存人数的增加，需要简单的工具来衡量和促进健康行为。我们创建了一个健康行为工具（SMILE 量表），以鼓励对健康行为进行自我监测。本研究旨在确定在癌症患者中每天收集自我报告的 SMILE 量表数据和每周生活质量数据的可行性。我们还旨在衡量 SMILE 量表反应与经过验证的健康相关生活质量（HRQOL）工具（PROMIS-29 + 2 和 SymTrak-8）之间的相关性，作为增加健康行为可能影响生活质量的假设的初步测试。
我们在印第安纳大学西蒙综合癌症中心调查了 100 名癌症患者。参与者被要求在两周内完成每日 SMILE 量表评估，以及每周 PROMIS-29 + 2 和 SymTrak-8 调查。主要终点是 SMILE 量表的完成率。本单臂试验研究的次要终点包括 SMILE 量表与其他 HRQOL 工具之间的相关性。
在 14 天的时间内，SMILE 量表的每日完成率在参与者中从 57%到 65%不等。在第一天完成 SMILE 的 61%的参与者中，有 87%在 14 天中的 10 天完成了 SMILE。到研究结束时，自我报告更多健康行为（即更高的每日 SMILE 得分）的参与者表现出更高的 PROMIS 身体健康（p = 0.003）、更高的 PROMIS 心理健康（p = 0.008）和更低的（更好）SymTrak 总症状负担（p = 0.006）。此外，在至少完成 14 天每日 SMILE 评估中的 1 次的参与者中，PROMIS 心理健康（p = 0.018）和 SymTrak 总症状负担（p = 0.014）在两周内的生活质量显著改善。
SMILE 量表的完成率没有满足我们预先计划的≥70%的可行性阈值；然而，在 14 天内至少完成一次 SMILE 的比例（77%）达到了这一阈值。平均每日 SMILE 得分较高的参与者在其他经过验证的 HRQOL 工具中得分明显更好。虽然这些结果可能是相关的而不是因果关系的，但这表明在临床实践中提供 SMILE 量表可能对促进健康行为有潜在的身心健康益处，并值得在未来的研究中测试 SMILE 量表的影响。
