A value affirmation intervention for physical symptoms and medication adherence in breast cancer patients taking aromatase inhibitors

项目摘要/摘要 这项研究的主要目的是评估一篇简短且有成本效益的肯定信的写作 干预减少乳腺癌患者的身体症状、压力和用药不依从性 服用芳香酶抑制剂(AIS)。大多数被诊断为乳腺癌的绝经后女性 开出一种人工智能；虽然有效，但这些药物会导致中毒的身体症状副作用特征和 忠诚度不高。针对这些副作用及其造成的压力的干预措施可能会带来改善 服药依从性，因此提高了接受AIS治疗的乳腺癌患者的生存率。在试点工作中 来自我们小组和其他人，在价值肯定干预中思考或撰写重要的个人价值观 与减少身体症状、减少压力和改善服药依从性有关。而当 这些最初的研究很有希望，样本很小，或者是横断面研究，并没有进行评估 干预效果的潜在神经生物学机制。拟议的研究将是随机的 对照试验(RCT)，比较为期6个月的便携式价值肯定书写干预(N=125)与 对服用芳香酶抑制剂的乳腺癌患者进行对照书写干预(N=125)。参与者将 完成自我报告的身体症状、依从性和压力的测量，在基线、干预后和 6个月随访。还将通过电子药瓶报告和重新灌装来评估服药依从性 研究期间的潜伏期。作为一个探索性的机械目标，来自父母的AI患者的一个子样本 随机对照试验(N=120，每个干预组60人)将完成其中期干预值确认或对照书写 在接受功能磁共振检查的同时完成任务。因此，拟议的研究将检验两个具体目标和一个探索性的 目的是确定：如果价值肯定写作减少了身体症状和压力(目标1)，则会有所改善 药物依从性(目标2)，以及价值肯定过程中的神经奖赏激活是否属于神经生物学 这些好处的机制(探索性目标1)。拟议的RCT有可能确定一个强大的、 经济高效且易于实施的价值肯定干预措施，可减轻症状、压力和 接受人工授精治疗的乳腺癌患者的用药不依从性。

PROJECT SUMMARY/ABSTRACT The broad aim of this research is to evaluate whether a brief and cost-effective value affirmation writing intervention reduces physical symptoms, stress and medication non-adherence among breast cancer patients taking aromatase inhibitors (AIs). The majority of postmenopausal women diagnosed with breast cancer will be prescribed an AI; and while effective, these medications lead to toxic physical symptom side effect profiles and poor adherence. Interventions that target these side effects and the stress they cause may lead to improved medication adherence and therefore improved survival rates for breast cancer patients taking AIs. In pilot work from our group and others, thinking or writing about important personal values in value affirmation interventions have been linked to fewer physical symptoms, decreased stress, and improved medication adherence. While promising, these initial studies had small samples or were cross sectional in nature, and did not evaluate potential neurobiological mechanisms for intervention effects. The proposed study will be a randomized controlled trial (RCT) comparing a 6-month, portable value affirmation writing intervention (N=125) to a control writing intervention (N=125) in breast cancer patients taking aromatase inhibitors. Participants will complete self-reported measures of physical symptoms, adherence and stress at baseline, post-intervention, and 6-month follow-up. Medication adherence will also be assessed via electronic pill bottle reporting and refill latency during the study period. As an exploratory mechanistic aim, a subsample of AI patients from the parent RCT (N=120, 60 per intervention arm) will complete their mid-intervention value affirmation or control writing task while undergoing functional MRI. Thus, the proposed study will test two specific aims and an exploratory aim to determine: if value affirmation writing reduces physical symptoms and stress (Aim 1), improves medication adherence (Aim 2), and if neural reward activation during value affirmation is a neurobiological mechanism for these benefits (Exploratory Aim 1). The proposed RCT has the potential to identify a powerful, cost-effective, and easy-to-implement value affirmation intervention for reducing symptoms, stress, and medication non-adherence in breast cancer patients taking AIs.