TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer (TOPCOP3): a Pilot RCT and Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- Number of participants with Grade 3-5 Toxicity
研究概览
简要总结
TOPCOP3 is a pilot factorial RCT of geriatric assessment and management, remote symptom monitoring, both interventions or neither, accompanied by an embedded process evaluation. This design is widely used to guide the evaluation of complex interventions and provides important data to aid design of larger RCTs. The trial itself falls within pilot trial goals including obtaining variance estimates for outcomes, assessment of recruitment potential, and understanding implementation issues vital to designing a larger trial. The investigators have clear feasibility objectives and an analytic plan as well as criteria to determine success and strong support from cancer advocacy and policy groups.
详细描述
Emerging data from supportive care intervention trials in people receiving chemotherapy suggest 2 different approaches - geriatric assessment and management (GA+M) and remote symptom monitoring (RSM) - may be associated with improved time on treatment, improved QOL, reduced toxicity, reduced unplanned health care use, and possibly prolonged overall survival. These 2 interventions have not been tested in combination or in people receiving treatments other than chemotherapy (such as ARATs). This RCT includes an embedded process evaluation of GA+M and RSM versus usual care to gather key efficacy and implementation data needed to design a definitive phase III RCT.
The next logical step in our research program is an intervention examining GA+M, RSM, or the combined intervention to improve the health and treatment tolerability for older men with mPC on ARATs. The pilot trial will gather key clinical outcome and feasibility data needed to inform a definitive phase III RCT; a necessary step in providing clinicians a greatly needed evidence-based supportive care intervention. The intervention was designed in partnership with patients and knowledge users, which will result in more relevant findings and greater health impact.
A total of 168 patients will be enrolled in the RCT across 2 centres. Based on TOPCOP1 and TOPCOP2, both of which included the two centres in TOPCOP3, the recruitment rate was 2-3 patients per week. There are 3-5 eligible patients per week across the two sites. Assuming a conservative recruitment rate of 50%, the investigators expect recruitment for this study to take 18 months.
Randomization will be centralized using REDCap, a secure web-based electronic data entry system. Patients will be allocated in a 1:1:1:1 ratio to GA+M, RSM, combined, or control, with stratification by mPC subtype (castration-sensitive or resistant) following recommended guidelines on number of strata. Permuted blocks of variable size will be used.
Given the nature of the intervention, it is not possible to blind patients or the project team to allocation. However, participants will be randomized, allocation will be concealed, variable permuted blocks will be used, 1 of the 2 co-primary outcomes will be assessed by blinded assessors (toxicity), validated measures will be used, several outcomes will be verified by independent data collection (treatment toxicity, overall survival), and the trial statistician will be blinded during the trial and during analysis of the main study results, similar to our 5C trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Given the nature of the intervention, it is not possible to blind patients or the project team to allocation, however, the statistician is blinded
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Starting an ARAT or started an ARAT within 2 weeks prior to being approached or switching ARATs due to progression or toxicity
- •Diagnosed with mPC (castration-sensitive or resistant) or nmCRPC (non-metastatic castration-resistant prostate cancer)
- •At least 65 years old
- •Able to provide written informed consent
- •Has a working telephone
排除标准
- •Unable to speak English (as contact with the nurse interventionist is via phone, not all outcome measures are available in multiple languages)
- •Major neuropsychiatric abnormalities (severe depression or moderate-severe dementia)
- •Life expectancy <3 months as estimated by the oncologist
研究组 & 干预措施
GA+M Intervention
GA+M intervention arm All participants in the GA+M intervention arm will undergo a standardized GA by a trained nurse and geriatrician. The GA will include 8 domains (comorbidity, medication review, function, falls risk, nutrition, social supports, cognition, and mood) similar to our 5C protocol.
Based on any detected abnormalities or issues, a standardized set of strategies will be implemented (e.g. increased falls risk will lead to detailed assessment of balance and gait, consideration of gait aid, and referral to outpatient physiotherapy). This follows the standard approach to implementing GA similar to recent trials in geriatric oncology including 5C. Telephone follow-ups at 1, 3 and 6 months by the nurse and review with the geriatrician as needed will be done to ensure identified issues have been addressed.
干预措施: GA+M Intervention (Other)
RSM Intervention
RSM Intervention All participants in the RSM intervention arm will receive once-weekly symptom monitoring via email-based surveys using the 9-item Edmonton Symptom Assessment Scale within a secure customized REDCap interface. If patients prefer, weekly telephone calls will be done instead by a research assistant to elicit If there are moderate or severe symptoms (score of 4+ out of 10), an oncology nurse will obtain more detailed symptom information and provide evidence-based symptom-targeted recommendations using the pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) Practice Guide. Symptom monitoring will continue for 6 months or discontinuation of treatment.
干预措施: RSM intervention (Other)
GA+RSM intervention
GA+RSM Combination Participants will receive both strategies as detailed above, with a GA at baseline.
干预措施: GA+RSM intervention (Other)
Control
Control Usual care consists of brief verbal education and a drug pamphlet to all patients when starting an ARAT. There is no GA+M and no RSM at either site. Patients have access to a 24x7 oncology nursing line or a 24/7 pharmacy line.
结局指标
主要结局
Number of participants with Grade 3-5 Toxicity
时间窗: 6 months
Grade 3-5 toxicity. This will be coded as at least one grade 3-5 toxicity vs none, measured based on review of clinical notes supplemented by interviews with patients by trained research staff and verified by a blinded physician. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Health related quality of life in patients with metastatic prostate cancer
时间窗: 6 months
QOL will be measured by patient self-report using the EQ-5D-5L, which is the EuroQol 5 dimensions of health questionnaire. This is a widely used, psychometrically valid brief generic QOL questionnaire.
次要结局
- Depression(6 months)
- Number of patients with decline in Instrumental Activities of Daily Living (IADL)(6 months)
- Number of patients with treatment discontinuation(6 months)
- Fatigue(6 months)
- Number of patients with treatment modification(6 months)
- Number of patients with severe symptoms(6 months)
- Insomnia(6 months)
- Anorexia and cachexia(6 months)
- Number of patients with unplanned health care(6 months)