Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
研究概览
简要总结
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:
- REVITALIZE
- Educational Materials
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •Willing to use a wireless pill bottle for PARP inhibitor medication.
排除标准
- •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.
研究组 & 干预措施
ARM 1: REVITALIZE Intervention
120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:
- Questionnaire upon enrollment.
- Use of a wireless pill bottle for PARP inhibitor medication.
- Eight weekly one-on-one intervention sessions with a coach via Zoom.
- Two booster sessions to reinforce intervention with a coach via Zoom.
- Questionnaires at 8, 13, 20, and 28 weeks.
干预措施: REVITALIZE Intervention (Behavioral)
ARM 2: Educational Materials
120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following:
- Questionnaire upon enrollment.
- Use of wireless pill bottle for PARP inhibitor medication.
- Educational information on cancer survivorship, including management of fatigue.
- Questionnaires at 8, 13, 20, and 28 weeks.
干预措施: Educational Materials (Behavioral)
结局指标
主要结局
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
时间窗: 20 weeks
Assessed by the 7-item Fatigue Interference subscale of the Fatigue Symptom Inventory (FSI). Items are rated on an 11-point scale (0 = no interference; 10 = extreme interference), with a total scores range of 0 to 70 with the higher score representing greater fatigue interference with daily life. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.
次要结局
- Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2)(8 weeks)
- Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2)(13 weeks)
- Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Emotional Distress: Anxiety Symptoms from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Emotional Distress: Anxiety Symptoms from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Emotional Distress: Depressive Symptoms from Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- Emotional Distress: Depressive Symptoms from Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- PARP Inhibitor Adherence Rate From Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- PARP Inhibitor Non-Persistence From baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- PARP Inhibitor Non-Persistence From baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 20 weeks (Arms 1 and 2)(20 weeks)
- PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 28 weeks (Arms 1 and 2)(28 weeks)
- Change in Value-Aligned Behavior Score From Baseline to 8 weeks (Arms 1 and 2)(8 weeks)
- Change in Value-Aligned Behavior Score From Baseline to 13 weeks (Arms 1 and 2)(13 weeks)
- Change in Acceptance and Cognitive Defusion from Baseline to 8 weeks (Arms 1 and 2)(8 weeks)
- Change in Acceptance and Cognitive Defusion from Baseline to 13 weeks (Arms 1 and 2)(13 weeks)
- Acceptability of Intervention (Arms 1 and 2)(20 weeks)
- Acceptability of Intervention (Arms 1 and 2)(13 weeks)
研究者
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute