Henry N L, Unger J M, Vaidya R, Darke A K, Skaar T C, Fisch M J, Hershman D L
University of Michigan Medical School, Ann Arbor, MI, United States of America.
Fred Hutchinson Cancer Center, Seattle, WA, United States of America; SWOG Statistics and Data Management Center, Seattle, WA, United States of America.
Contemp Clin Trials. 2024 Dec;147:107712. doi: 10.1016/j.cct.2024.107712. Epub 2024 Oct 10.
Premenopausal women with early stage, high risk hormone receptor positive breast cancer are at risk of early discontinuation of adjuvant endocrine therapy (ET), primarily because of toxicity, which can increase the risk of disease recurrence and death. We hypothesize that identification of bothersome symptoms between clinic visits, and automated notification of clinicians about symptoms, will result in improved persistence with ET.
Pre- and perimenopausal women planning to receive adjuvant treatment with tamoxifen or an aromatase inhibitor plus ovarian function suppression or ablation for treatment of breast cancer are eligible. A total of 540 participants will be enrolled and randomized 1:1 to patient education with or without Active Symptom Monitoring (ASM). The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email, or telephone weekly for 24 weeks, then every 4 weeks for 48 weeks. All participants will complete a battery of questionnaires every 12 weeks to examine symptoms, beliefs about medicine, self-efficacy, and ET adherence. Optional blood draws will be collected at baseline and after 12, 48, and 72 weeks of therapy to examine estradiol and ET concentrations. The primary endpoint is time to nonpersistence with initially prescribed ET within the first 72 weeks, evaluated using Kaplan-Meier plots and multivariable Cox regression.
We expect early identification and management of ET-related toxicities to improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for premenopausal women at high risk of breast cancer recurrence.
govNCT05568472.
患有早期、高危激素受体阳性乳腺癌的绝经前女性存在辅助内分泌治疗（ET）提前中断的风险，主要原因是毒性反应，这会增加疾病复发和死亡的风险。我们假设，在门诊就诊期间识别出令人烦恼的症状，并自动向临床医生通报这些症状，将提高ET治疗的依从性。
计划接受他莫昔芬或芳香化酶抑制剂联合卵巢功能抑制或切除进行辅助治疗以治疗乳腺癌的绝经前和围绝经期女性符合条件。总共将招募540名参与者，并按1:1随机分为接受或不接受主动症状监测（ASM）的患者教育组。ASM干预包括6个症状问题（潮热、悲伤、焦虑、失眠、阴道干燥、关节疼痛），将通过短信、电子邮件或电话每周完成一次，持续24周，然后每4周完成一次，持续48周。所有参与者将每12周完成一系列问卷，以检查症状、对药物的信念、自我效能感和ET治疗依从性。在基线以及治疗12周、48周和72周后将进行可选的血液检查，以检测雌二醇和ET浓度。主要终点是在最初规定的ET治疗的前72周内不持续治疗的时间，使用Kaplan-Meier曲线和多变量Cox回归进行评估。
我们期望早期识别和管理与ET相关的毒性反应，以提高乳腺癌复发高危绝经前女性的乳腺癌治疗依从性、乳腺癌治疗效果和生活质量。
govNCT05568472
