Nonpharmacologic Interventions for Fatigue in Patients With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in fatigue
研究概览
简要总结
This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer.
The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of POWER exercise program.
SECONDARY OBJECTIVES:
I. To evaluate the change in fatigue from baseline to week 12 in patients with prostate cancer who completed both baseline and 12 week assessments, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
II. To evaluate the change in cardiorespiratory fitness from baseline to Week 12, as assessed with the graded exercise test, with 12 weeks of the POWER exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with advanced prostate cancer
- •Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
- •A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??
- •Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year
- •Physically able to exercise and physician consent to start an exercise program
- •Regular access to a computer with internet service
- •Must be able to read and understand English
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
排除标准
- •Evidence of disease progression at the time of enrollment
- •Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
- •Prior cognitive-behavioral therapy
研究组 & 干预措施
Exercise - Arm I
Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks.
干预措施: Exercise Intervention (Behavioral)
Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)
Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based CBT intervention over 12 weeks.
干预措施: Cognitive Behavior Therapy (Behavioral)
Exercise plus PROSPECT Cognitive Behavior Therapy (CBT)
Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based CBT intervention over 12 weeks.
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Change in fatigue
时间窗: Baseline up to 12 weeks post intervention (24 weeks)
Change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
次要结局
- Change in Quality of Life(Baseline up to 12 weeks post intervention (24 weeks))
- Change in activity level(Baseline up to 12 weeks post intervention (24 weeks))