Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue.

Autor: Wright AA; 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. Electronic address: alexi_wright@dfci.harvard.edu., Poort H; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA., Tavormina A; Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA., Schmiege SJ; Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Center Campus, Aurora, CO, USA., Matulonis UA; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Campos SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Liu JF; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Slivjak ET; University of Colorado Boulder, Boulder, CO, USA., Gilmour AL; University of Colorado Boulder, Boulder, CO, USA., Salinger JM; University of Colorado Boulder, Boulder, CO, USA., Haggerty AF; PENN Medicine, University of Pennsylvania Health System, Philadelphia, PA, USA., Arch JJ; University of Colorado Boulder, Boulder, CO, USA; Cancer Prevention and Control Program, University of Colorado Cancer Center, Anschutz Medical Center Campus, School of Medicine, Aurora, CO, USA.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2023 Oct; Vol. 177, pp. 165-172. Date of Electronic Publication: 2023 Sep 13.
DOI: 10.1016/j.ygyno.2023.08.020
Abstrakt: Objective: 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.
Methods: 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.
Results: 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%).
Conclusions: 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.)
Databáze: MEDLINE
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