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.

项目概要/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 的坚持率低至 25%，这可能导致不良 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。 列举了不坚持 AHT 的原因。患者还报告了一系列阻碍 AHT 坚持的障碍， 包括：在认知层面，女性对 AHT 的功效持负面看法，癌症风险低 复发恐惧，以及缺乏防止无意中漏服剂量的行为提示。 包括对其副作用的困扰以及对其长期使用影响的高度担忧。 人际关系水平、家庭支持度低以及与提供者的沟通不畅与 AHT 有关 然而，我们对促进 AHT 依从性的有效干预措施知之甚少。 团队的认知社会健康信息处理模型和健康沟通最佳实践， 基于证据的移动短信干预 (Txt2Adhere) 是与患者一起迭代开发的 Txt2Adhere 的目标是解决 1) 认知问题。 通过增加有关 AHT 的知识、强化 AHT 的益处以及提供药物治疗技能来克服障碍 2）通过情绪正常化和提供自我管理技能来管理压力来消除情感障碍 和症状；3）通过增强妇女与家人的沟通技巧来消除人际障碍； 在一项试点研究中，Txt2Adhere 参与者报告 2 个月时对 AHT 的依从性显着提高， 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) 将干预期延长至六个月；2）跟踪参与者一年；3）添加无线智能设备； 药瓶组件；4) 包括较大的样本，用于拟议研究的第一阶段，焦点小组。 并将进行行为科学顾问小组审查，以最终确定改进和增强 在第 2 阶段，我们将评估 Txt2Adhere 对不同 BCa 患者组的疗效。 (N=300) 与从 Fox Chase 癌症中心和天普大学招募的 UC 组进行比较 医院总共将进行四次评估：基线评估、3 个月评估、6 个月评估和 12 个月评估（6- 干预后几个月）的随访结果和过程变量包括 AHT 依从性评估。 率（通过 AdhereTech 智能药瓶测量）、症状困扰、基于理论的变量、干预 参与者对干预的满意度和使用情况我们参与了 Txt2Adhere 参与者的意愿。 与 UC 相比，AHT 依从率明显更高，症状困扰水平更低 我们将确定认知情感障碍的减少是否会介导干预的效果。 我们将探讨少数民族、年轻人或老年人是否会减轻这项研究的影响。 意义重大，因为 Txt2Adhere 有可能减少 BCa 女性中持续的 AHT 不依从性。

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