Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA; Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA.
Gynecol Oncol. 2023 Oct;177:165-172. doi: 10.1016/j.ygyno.2023.08.020. Epub 2023 Sep 13.
Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed treatment for advanced ovarian cancer, but nearly half of patients experience significant fatigue. We conducted a two-site pilot randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a brief, acceptance-based telehealth intervention (REVITALIZE) designed to reduce fatigue interference in patients on PARPi.
From June 2021 to April 2022, 44 participants were randomized 1:1 to REVITALIZE (6 weekly one-on-one sessions+booster) or enhanced usual care. Feasibility was defined as: ≥50% approach-to-consent among potentially eligible patients and ≥70% completion of 12-week follow-up assessment; acceptance was <20% participants reporting burden and <20% study withdrawal. Fatigue, anxiety, depression, and quality of life were assessed at baseline, 4-, 8- and 12-weeks.
Among 44 participants (mean age = 62.5 years, 81.8% stage III/IV disease), the study was feasible (56.4% approach-to-consent ratio, 86.3% completion of 12-week assessment) and acceptable (0% reporting burden, 11.3% study withdrawal). At 12-week follow-up, REVITALIZE significantly reduced fatigue interference (Cohen's d = 0.94, p = .008) and fatigue severity (d = 0.54, p = .049), and improved fatigue levels (d = 0.62, p = .04) relative to enhanced usual care. REVITALIZE also showed promise for improved fatigue self-efficacy, fatigue catastrophizing, anxiety, depression, and quality of life (ds = 0.60-0.86, p ≥ .05). Compared with enhanced usual care, REVITALIZE participants had fewer PARPi dose reductions (6.7% vs. 19.0%), and dose delays (6.7% vs. 23.8%).
Among fatigued adults with ovarian cancer on PARPi, a brief, acceptance-based telehealth intervention was feasible, acceptable, and demonstrated preliminary efficacy in improving fatigue interference, severity, and levels. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation.
聚（ADP-核糖）聚合酶抑制剂（PARPi）显著改变了晚期卵巢癌的治疗方法，但近一半的患者会出现严重疲劳。我们进行了一项两站点的先导随机试验，以评估一项旨在减轻 PARPi 治疗患者疲劳干扰的简短、基于接受度的远程医疗干预（REVITALIZE）的可行性、可接受性和初步疗效。
从 2021 年 6 月至 2022 年 4 月，44 名参与者按照 1:1 的比例随机分为 REVITALIZE（6 周一次的一对一课程+强化剂）或增强型常规护理。可行性定义为：有潜力的合格患者中至少有 50%的人愿意接受治疗，并且至少有 70%的患者完成了 12 周的随访评估；接受度定义为：<20%的参与者报告有负担，<20%的参与者退出研究。基线、4 周、8 周和 12 周时评估疲劳、焦虑、抑郁和生活质量。
在 44 名参与者（平均年龄 62.5 岁，81.8%为 III/IV 期疾病）中，该研究是可行的（56.4%的意向性同意率，86.3%的 12 周评估完成率）和可接受的（0%的参与者报告有负担，11.3%的参与者退出研究）。在 12 周的随访中，与增强型常规护理相比，REVITALIZE 显著降低了疲劳干扰（Cohen's d=0.94，p=0.008）和疲劳严重程度（d=0.54，p=0.049），并改善了疲劳水平（d=0.62，p=0.04）。REVITALIZE 还显示出改善疲劳自我效能、疲劳灾难化、焦虑、抑郁和生活质量的潜力（ds=0.60-0.86，p≥0.05）。与增强型常规护理相比，REVITALIZE 组 PARPi 的剂量减少（6.7%比 19.0%）和剂量延迟（6.7%比 23.8%）较少。
在接受 PARPi 治疗的卵巢癌疲劳成人中，一项简短的、基于接受度的远程医疗干预是可行的、可接受的，并初步显示出改善疲劳干扰、严重程度和水平的疗效。REVITALIZE 是一种新颖的、可扩展的远程医疗干预措施，值得进一步研究。
