目的:本研究旨在比较基于社会认知理论的移动健康干预与标准护理对最大张口的影响。行使合规性,接受质子和重离子治疗的头颈部癌症患者的自我效能。
方法:这个开放标签,平行组,随机化,优势试验涉及自行开发的“健康享受系统”干预措施。我们评估了最大张口,行使合规性,和基线自我效能感(T0),治疗后(T1),放疗后1个月(T2)和3个月(T3)。广义估计方程用于分析各组之间随时间的差异,结果报告为P值和95%置信区间(CI)。
结果:该研究包括44名参与者。在T3时,干预组比对照组的最大切缝开口增加了6mm(平均差异=6.0,95%CI=2.4至9.5,P=0.001)。两组之间的运动依从性也存在显着差异(平均差异=31.7,95%CI=4.6至58.8,P=0.022)。然而,两组的自我效能感没有显著差异.
结论:这项研究表明,在中国接受质子和重离子治疗的头颈癌患者中,结合行为改变理论的mHealth干预措施可以有效增强或维持最大张口。这种方法在治疗期间和治疗后提供了有价值的支持。
背景:ChiCTR:ChiCTR2300067550。注册于2023年1月11日。
OBJECTIVE: This study aimed to compare the effects of a mobile health intervention based on social cognitive theory with standard care on maximal mouth opening, exercise compliance, and self-efficacy in patients receiving proton and heavy ion therapy for head and neck cancer.
METHODS: This open-label, parallel-group, randomized, superiority trial involved a self-developed \"Health Enjoy System\" intervention. We assessed maximal mouth opening, exercise compliance, and self-efficacy at baseline (T0), post-treatment (T1), and at 1 month (T2) and 3 months (T3) after radiotherapy. Generalized estimating equations were used to analyze differences between the groups over time, with results reported as P values and 95% confidence intervals (CIs).
RESULTS: The study included 44 participants. At T3, the intervention group showed a 6 mm greater increase in maximal interincisal opening than the control group (mean difference = 6.0, 95% CI = 2.4 to 9.5, P = 0.001). There was also a significant difference in exercise compliance between the groups (mean difference = 31.7, 95% CI = 4.6 to 58.8, P = 0.022). However, no significant difference in self-efficacy was found between the groups.
CONCLUSIONS: This study demonstrated that an mHealth intervention incorporating behavior change theory could effectively enhance or maintain maximal mouth opening in patients undergoing proton and heavy ion therapy for head and neck cancer in China. This approach provides valuable support during and after treatment.
BACKGROUND: ChiCTR: ChiCTR2300067550. Registered 11 Jan 2023.