一项针对卵巢癌及PARP抑制剂相关疲劳的接受为基础的远程健康干预的试验性随机研究。
Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue.
发表日期:2023 Sep 12
作者:
Alexi A Wright, Hanneke Poort, Anna Tavormina, Sarah J Schmiege, Ursula A Matulonis, Susana M Campos, Joyce F Liu, Elizabeth T Slivjak, Anna L Gilmour, Julia M Salinger, Ashley F Haggerty, Joanna J Arch
来源:
GYNECOLOGIC ONCOLOGY
摘要:
Poly(ADP-ribose)聚合酶抑制剂(PARPi)在晚期卵巢癌的治疗中产生了显著的变革,但近一半的患者会出现明显的疲劳。我们进行了一个双中心的小规模随机试验,以评估一种简要的、基于接纳的远程医疗干预(REVITALIZE)的可行性、可接受性和初步疗效,该干预旨在减少PARPi患者的疲劳干扰。从2021年6月至2022年4月,我们将44名参与者随机分配为REVITALIZE组(6周一对一会话+加强干预)或增强常规护理组。可行性定义为:潜在符合条件的患者中,≥50% 同意参与; 12周后随访评估的完成率≥70%;可接受性定义为:报告负担感的参与者比例<20%,退出研究的参与者比例<20%。我们在基线、4周、8周和12周评估了疲劳、焦虑、抑郁和生活质量。在44名参与者中(平均年龄=62.5岁,81.8%为III/IV期疾病),研究是可行的(56.4% 同意参与率,86.3% 完成12周评估),并且是可接受的(0% 报告负担感,11.3% 退出研究)。在12周随访时,相对于增强常规护理,REVITALIZE显著减少了疲劳干扰(Cohen's d = 0.94, p = .008),降低了疲劳严重程度(d = 0.54, p = .049),并改善了疲劳水平(d = 0.62, p = .04)。REVITALIZE在改善疲劳自我效能、疲劳灾难思维、焦虑、抑郁和生活质量方面也显示出潜力(ds = 0.60-0.86, p ≥ .05)。与增强常规护理相比,REVITALIZE组参与者的PARPi剂量减少(6.7% vs. 19.0%)和剂量延迟(6.7% vs. 23.8%)都较少。对于PARPi治疗下疲劳成年卵巢癌患者而言,这种简要的、基于接纳的远程医疗干预是可行的、可接受的,并且具有改善疲劳干扰、严重程度和水平方面的初步疗效。REVITALIZE是一种新颖、可扩展的远程医疗干预措施,值得进一步研究。版权所有 © 2023 Elsevier Inc.。保留所有权利。
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.Copyright © 2023 Elsevier Inc. All rights reserved.