REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors

Официальное название

Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors

Обзор

The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors. The name of the study groups in this research study are: 1. REVITALIZE 2. Educational Materials

Подробное описание

This Phase 3 randomized controlled trial will evaluate the effect of a brief, acceptance-based tele-health intervention (REVITALIZE) vs. educational materials in participants with ovarian cancer who are taking poly-ADP ribose polymerase (PARP) inhibitors.

Participants will be randomized into one of two study groups: 1) REVITALIZE or 2) Educational Materials. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, using a wireless pill bottle, and completing questionnaires.

Participation in this research study is expected to last about 7 months.

It is expected about 240 people will take part in this research study.

The National Cancer Institute is supporting this research by providing funding.

Вмешательства

• Поведенческое REVITALIZE Intervention
  A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via t
• Поведенческое Educational Materials
  The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute

Первичные конечные точки

• Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]

Вторичные конечные точки (12)

• Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2) [Срок оценки: 28 weeks]
• Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]
• Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2) [Срок оценки: 28 weeks]
• Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]
• Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2) [Срок оценки: 28 weeks]
• Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]
• Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2) [Срок оценки: 28 weeks]
• Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2) [Срок оценки: 8 weeks]
• Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2) [Срок оценки: 13 weeks]
• Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]
• Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2) [Срок оценки: 20 weeks]
• Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2) [Срок оценки: 28 weeks]

Критерии участия

Критерии включения

• Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).
• Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.
• English-speaking.
• Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.
• ECOG performance status of 0-2.
• Willing to use a wireless pill bottle for PARP inhibitor medication.

Критерии исключения

• Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.
• Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.
• Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.
• Inability to complete the first questionnaire within one week of consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 6 центров

• University of Colorado Cancer Center-Anschutz — Aurora
• University of Colorado Boulder — Boulder
• Massachusetts General Hospital-Cancer Center — Boston
• Beth Israel Deaconess Medical Center — Boston
• Dana-Farber Cancer Institute — Boston
• Duke Cancer Center — Durham

Публикации

• Arch JJ, Uno H, Poort H, Slivjak E, Nealis MS, Park H, Wang I, Genung SR, Cronin A, Andorsky DJ, Havrilesky LJ, Penson RT, Mazina V, Widick P, Lefkowits C, Wright AA. Randomized clinical trial of an Acceptance and Commitment Therapy telehealth intervention ('REVITALIZE') to reduce fatigue interference in women with advanced ovarian cancer on PARP inhibitors: study protocol. BMC Cancer. 2026 Apr 2; PMID 41928160

Идентификаторы

NCT: NCT06710548 · 24-105 · R01CA289547

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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