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

基于移动 TXT 的干预措施可提高 BCa 幸存者对辅助激素治疗和症状管理的依从性

• 批准号: 10524099
• 负责人: Kuang-Yi Wen
• 金额: $ 19.76万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-11 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10524099
• 关键词: Address; Adherence; Adjuvant; Adopted; Affective; Age; Behavioral; Belief; Breast Cancer Patient; Breast Cancer survivor; Breast Cancer therapy; Caring; Chronic Disease; Clinical; Cognitive; Communication; Cues; Data; Diagnosis; Disease; Disease Management; Distress; Dose; Effectiveness; Ethnic Origin; Evaluation; Family; Feeling; Focus Groups; Fox Chase Cancer Center; Fright; Funding; Future; Goals; Health; Intervention; Knowledge; Lead; Maintenance; Measures; Mediating; Mediator of activation protein; Minority; Minority Women; Modeling; Oncology; Oral; Outcome; Participant; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Preventive; Process; Provider; Psychosocial Assessment and Care; Race; Randomized; Randomized Clinical Trials; Recurrence; Recurrent disease; Regimen; Reporting; Research; Sampling; Self Management; Social support; Subgroup; Symptoms; System; Text Messaging; Time; Treatment Efficacy; University Hospitals; Woman; adherence rate; anti-cancer; base; cancer recurrence; cancer therapy; cancer type; clinical efficacy; community setting; compliance behavior; cost effective; design; effective intervention; efficacy evaluation; efficacy testing; evidence base; experience; family support; group intervention; health communication; hormone receptor-positive; hormone therapy; improved; information processing; innovation; intervention effect; intervention participants; mHealth; malignant breast neoplasm; medication compliance; mortality; negative affect; novel; patient oriented; patient-level barriers; pill; post intervention; prevent; recruit; satisfaction; side effect; skills; social; social cognitive theory; success; successful intervention; survival outcome; symptom management; symptomatic improvement; systematic review; text messaging intervention; theories; therapy adherence; therapy design; tool; treatment as usual; uptake; wireless; young woman

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.

项目总结/摘要 大量证据表明，辅助激素治疗（AHT）可减少乳腺癌（BCa）复发 然而，据报道，AHT的依从率低至25%，这可能导致不良的 生存结果。AHT的副作用可对HRQOL产生负面影响，并且是最常见的副作用之一。 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：在认知水平上，女性对AHT的疗效持负面看法， 复发恐惧，以及缺乏行为线索来防止无意中错过剂量。在情感层面， 障碍包括对副作用的忧虑和对长期使用的影响的高度关注。在 人际关系水平、家庭支持度低和与提供者沟通不良与AHT相关 不依从。然而，关于有效的AHT依从性促进干预措施知之甚少。引导我们的 团队的认知-社会健康信息处理模型和健康传播最佳实践， 基于证据的移动的短信干预（Txt 2Adhere）是与患者反复开发的， 集中的输入和临床和行为评估。Txt 2Adhere的目标是解决1）认知 通过增加有关AHT的知识，加强AHT的好处，并提供药物治疗的技能， 吸收; 2）情感障碍，通过正常化感受和提供自我管理技能来管理痛苦 3）人际交往障碍，加强妇女与家人的沟通技巧， 提供商在一项试点研究中，Txt 2Adhere参与者报告在2个月时对AHT的依从性显著提高， 与UC组相比。拟议的研究创新地建立在我们试点研究的成功基础上：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）包括较大的样品。在拟议研究的第一阶段， 并将进行行为科学咨询小组审查，以最终确定改进和加强 关于Txt 2Adhere在第2阶段，我们将评估Txt 2Adhere对不同BCa患者组的疗效 （N=300）与UC组相比，从Fox Chase癌症中心和坦普尔大学招募 医院共进行4次评估：基线、3个月、6个月和12个月（6- 12个月）。 干预后3个月）随访。结果和过程变量包括对AHT依从性的评估 率（通过AdhereTech智能药瓶测量），症状困扰，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Txt 2Adhere参与者将 报告AHT依从率显著高于UC，症状困扰水平显著低于UC 组我们将确定认知情感障碍的减少是否介导了干预的效果。 我们将探讨是否是少数民族，年轻或老年人适度的干预措施的影响。这项研究是 这是因为Txt 2Adhere有可能减少BCa女性中持续的AHT不依从性。