Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI) to measure treatment related insomnia
研究概览
简要总结
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Multicentre pilot study (n=90) which aims to study a prevalent population of elderly or frail patients with mCRPC whom are often excluded from clinical trial participation. (Data is sorely needed in this population)
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The study aims to determine:
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if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC
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The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223
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If changes in physical activity (quantified by fitbit) predict for changes to ESAS in men undergoing treatment d) Qualitatively assess the supportive care needs of older/frail men with mCRPC
详细描述
Study Aim:
The previous multi-centre observational study (TOPCOP), funded by Prostate Cancer Canada, demonstrated important declines in multiple areas of quality of life, and fatigue and functional decline which were common issues that often limited further treatment. Emerging data from other settings demonstrate that (a) close monitoring of symptoms may reduce treatment toxicity and improve survival; (b) improving physical activity and targeting pain and sleep may improve fatigue and function. Whether these are feasible in the setting of older or frail men with mCRPC is unclear. Incorporating what the investigators have learned from TOPCOP and emerging supportive oncology literature, our main aim is to examine the emergence of key symptoms (fatigue, pain, insomnia) and explore whether reductions in daily physical activity are early indicators of toxicity over one treatment cycle (3-4 weeks) and therefore targetable in a subsequent intervention study.
Study Design:
This is a prospective multicentre observational study. The investigators will enroll English-speaking men with mCRPC who are either age 75 or older or age 60-74 and frail using (a) chemotherapy; (b) abiraterone or enzalutamide; (c) Radium.
Daily telephone-based brief symptom screening will be done with the Edmonton Symptom Assessment Scale (ESAS). Daily monitoring of physical activity (step counts) will be done with commercial smartphone apps or a Fitbit device. Moderate or higher symptoms (>3/10) on ESAS or a decrease in daily step count of 15% or more triggers more detailed telephone-based toxicity assessment and measures of pain, sleep, and fatigue as appropriate. The study duration is 3 weeks (1 cycle of chemotherapy) or 4 weeks (abiraterone/enzalutamide/radium). Qualitative interviews will be done to explore challenges with treatment tolerability and adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Starting either chemotherapy, Radium-223, Abiraterone or Enzalutamide or starting chemo > one year post CHAARTED
- •At least 65 years old
- •Able to provide written informed consent
- •Diagnosed with metastatic castrate resistant prostate cancer
- •Total Testosterone level 1.7nmol/L
- •Has a working smartphone OR is willing to use a study provided smartphone
排除标准
- 未提供
结局指标
主要结局
Insomnia Severity Index (ISI) to measure treatment related insomnia
时间窗: 3-4 weeks
Number of participants with ESAS insomnia score greater than 3 that triggered ISI
Patient Health Questionnaire 9-item (PHQ-9) to measure treatment related depression
时间窗: 3-4 weeks
Number of participants with ESAS depression score greater than 3 that triggered PHQ-9.
Brief Pain Inventory-Short Form (BPI-SF) to measure pain severity
时间窗: 3-4 weeks
Number of participants with ESAS pain score greater than 3 that triggered BPI-SF. than 3
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) to measure fatigue
时间窗: 3-4 weeks
Number of participants with ESAS fatigue score greater than 3 that triggered MFSI-SF.
Generalized Anxiety Disorder 7-item (GAD) to measure treatment related anxiety
时间窗: 3-4 weeks
Number of participants with ESAS anxiety score greater than 3 that triggered GAD
Daily monitoring with Edmonton Symptom Assessment Scale (ESAS)
时间窗: 3-4 weeks
Number of participants with treatment-related adverse events as measured by ESAS.Moderate or higher symptoms (\>3/10) on ESAS triggers more detailed telephone-based toxicity assessment
Using a personal physical activity tracker step counts are monitored daily.
时间窗: 3-4 weeks
Number of participants with a decrease in daily step count of 15% or more that triggers more detailed telephone-based assessment.
次要结局
- Study Completion Questionnaire to measure participant burden and satisfaction(5 minutes)
- Participants symptom experience by Qualitative interview(30 minutes)