A Mobile TXT-based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors

项目摘要/摘要 大量证据表明，辅助激素治疗(AHT)可降低乳腺癌(BCA)的复发 然而，据报道，AHT的依从率低至25%，这可能会导致贫困 生存结果。AHT的副作用会对HRQOL产生负面影响，是最常见的 列举了不遵守AHT的原因。患者还报告了AHT依从性的一系列障碍， 包括：在认知层面上，女性对AHT(低癌)的疗效持负面看法 对复发的恐惧，以及缺乏行为线索来防止意外遗漏剂量。在情感层面上， 障碍包括对副作用的苦恼和对长期使用它的影响的高度关注。在 人际关系水平、家庭支持程度低以及与提供者沟通不畅都与AHT有关 不坚持。然而，关于有效的促进AHT依从性的干预措施知之甚少。由我们的指导 团队的认知-社会健康信息处理模型和健康沟通最佳实践，以及 循证移动短信干预(Txt2Adhere)是与患者一起迭代开发的 集中输入以及临床和行为评估。Txt2Adhere的目标是解决1)认知 通过增加有关AHT的知识、加强AHT的益处和提供药物治疗技能来设置障碍 理解；2)通过正常化情绪和提供自我管理技能来管理痛苦的情感障碍 和症状；以及3)通过提高妇女与家庭的沟通能力和 供应商。在一项先导性研究中，Txt2 Adhere参与者报告说，在2个月后，他们对AHT的依从性显著更高， 与UC组比较。拟议的研究创新性地建立在我们先导研究的成功基础上：1) 将干预期延长至6个月；2)跟踪参与者1年；3)增加无线智能 药瓶组件；以及4)包括更大的样品。在拟议研究的第一阶段，重点小组 并将进行行为科学咨询小组审查，以最终完成改进和增强 Txt2Adhere.在第二阶段，我们将评估Txt2粘附剂在不同组BCA患者上的疗效 (n=300)与从Fox Chase癌症中心和坦普尔大学招募的UC组进行比较 医院。总共将进行四次评估：基线、3个月、6个月和12个月(6- 干预后几个月)随访。结果和过程变量包括对AHT遵从性的评估 比率(由AdherTech智能药瓶测量)、症状苦恼、基于理论的变量、干预 参与者对干预措施的满意度和使用情况。我们假设Txt2附加参与者将 报告称，与UC相比，AHT遵从率显著更高，症状困扰水平更低 一群人。我们将确定认知-情感障碍的减少是否会影响干预的效果。 我们将探索少数民族、年轻人或老年人是否会缓和干预的效果。这项研究是 重要的是因为Txt2 Adhere有可能减少BCA女性中持续的AHT不依从性。

PROJECT SUMMARY/ABSTRACT Substantial evidence reports that adjuvant hormone therapy (AHT) decrease breast cancer (BCa) recurrence and mortality, however, rates of adherence to AHT have reported to be as low as 25%, which can lead to poor survival outcomes. Side effects from AHT can negatively affect HRQOL and are one of the most commonly cited reasons for nonadherence to AHT. Patients also reported a range of barriers to AHT adherence, including: at the cognitive level, women report negative beliefs about the efficacy of AHT, low cancer recurrence fears, and a lack of behavioral cues to prevent unintentionally missing doses. At the affective level, barriers include distress about side effects and high concerns regarding the impact of its long-term use. At the interpersonal level, low family support and poor communication with providers have been associated with AHT nonadherence. However, little is known about effective AHT adherence-promoting interventions. Guided by our team’s Cognitive-Social Health Information Processing Model and health communication best practices, an evidence-based mobile text messaging intervention (Txt2Adhere) was iteratively developed with patient- centered input and clinical and behavioral evaluation. The goal of Txt2Adhere is to address 1) cognitive barriers by increasing knowledge about AHT, reinforcing AHT benefits, and providing skills for medication uptake; 2) affective barriers by normalizing feelings and providing self-management skills to manage distress and symptoms; and 3) interpersonal barriers by enhancing women’s communication skills with families and providers. In a pilot study, Txt2Adhere participants reported significantly higher adherence to AHT at 2 months, compared with a UC group. The proposed study innovatively builds on the success of our pilot study by: 1) expanding the intervention period to six months; 2) following participants for 1 year; 3) adding a wireless smart pill bottle component; and 4) including a larger sample. For the phase 1 of the proposed study, focus groups and a behavioral scientific advisory panel review will be conducted to finalize the refinement and enhancement of Txt2Adhere. During phase 2, we will evaluate the efficacy of Txt2Adhere on a diverse group of BCa patients (N=300) in comparison with a UC group, recruited from Fox Chase Cancer Center and Temple University Hospital. A total of four assessments will be conducted: baseline, 3-months, 6-months, and 12-months (6- months post-intervention) follow-ups. Outcome and process variables include assessment of AHT adherence rate (measured by AdhereTech smart pill bottles), symptom distress, theory-based variables, intervention participant satisfaction with and usage of the intervention. We hypothesize that Txt2Adhere participants will report significantly higher levels of AHT adherence rates and lower levels of symptom distress than the UC group. We will determine if the reduction in cognitive-affective barriers mediates the effects of the intervention. We will explore if being minority, younger or older moderate the effects of the intervention. The study is significant because Txt2Adhere has the potential to reduce persistent AHT nonadherence among BCa women.