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: 10657455
• 负责人: Kuang-Yi Wen
• 金额: $ 49.79万
• 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/10657455
• 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; Hormones; Institution; Intervention; Knowledge; Maintenance; Measures; Mediating; Mediator; Minority; Minority Women; Modeling; Oncology; Oral; Outcome; Participant; Patient Education; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Preventive; Process; Provider; Psychosocial Assessment and Care; Race; Randomized; Recurrence; Recurrent Malignant Neoplasm; 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; 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; provider communication; randomized, clinical trials; 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.

项目摘要/摘要 大量证据报告说，可调节的马龙治疗（AHT）减少乳腺癌（BCA）复发 然而，死亡率据报道遵守AHT的比率高达25％，这可能导致较差 生存结果。 AHT的副作用会对HRQOL产生负面影响，并且是最常见的副作用之一 引用了不依从的原因。患者还报告了AHT依从性的一系列障碍， 包括：在认知水平上，妇女报告对AHT效率，低癌症的负面信念 复发恐惧，缺乏行为提示，以防止无意间缺少剂量。在情感层面， 障碍包括对副作用的困扰以及对其长期使用影响的高度关注。在 人际关系水平，家庭支持低和与提供者的沟通不良与AHT有关 不遵守。但是，对于有效的AHT依从性干预措施知之甚少。由我们的指导 团队的认知社会健康信息处理模型和健康交流最佳实践，这是一个 基于证据的移动文本消息干预措施（TXT2Adhere）是通过患者迭代开发的 中心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，增强AHT益处并为药物提供技能来障碍 吸收2）通过标准化感受并提供自我管理技能来管理困境，情感障碍 和符号； 3）通过增强女性与家人的沟通技巧和人际障碍 提供者。在一项试点研究中，TXT2Adhere参与者报告了2个月对AHT的依从性明显更高， 与UC组相比。拟议的研究创新的基于我们的试点研究的成功：1） 将干预期扩大到六个月； 2）跟随参与者一年； 3）添加无线智能 药瓶成分； 4）包括更大的样本。对于拟议研究的第一阶段，焦点小组 并将进行行为科学咨询小组审查，以最终确定改进和增强 txt2adhere。在第2阶段，我们将评估TXT2Adhere在BCA患者的潜水员组中的效率 （n = 300）与UC组相比，从福克斯大通癌中心和坦普尔大学招募 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评估AHT依从性 速率（通过Adheretech智能药瓶衡量），症状遇险，基于理论的变量，干预 参与者对干预的满意和使用。我们假设TXT2Adhere参与者将 报告的AHT依从性率和症状困扰水平明显高于UC 团体。我们将确定降低认知影响屏障是否介导了干预措施的影响。 我们将探索是少数，年轻或以上的少数群体是否会减轻干预的影响。这项研究是 意义重大，因为TXT2Adhere有可能减少BCA妇女的持续性AHT不坚持。

项目成果

The lived experience of patients with breast cancer on adjuvant endocrine therapy: side effects and coping strategies during the first year of medication initiation.

乳腺癌患者接受辅助内分泌治疗的生活经验：药物治疗第一年的副作用和应对策略。

• DOI: 10.1007/s00520-023-08170-y
• 发表时间: 2023
• 期刊: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
• 作者: Gomaa,Sameh;Lopez,AnaMaria;Slamon,Rachel;Smith,Rita;Lapitan,Emmanuel;Nightingale,Ginah;Miller,SuzanneM;Wen,Kuang-Yi
• 通讯作者: Wen,Kuang-Yi