A Study Of Remote Patient Monitoring (RPM) Program For Cancer Patients Initiating Cancer-directed Therapy
2026年9月9日 更新者:Mayo Clinic
Development And Pilot Implementation Of A Novel Remote Patient Monitoring Program For Cancer Patients Initiating Cancer-directed Therapy: The SHIELD (Smart Health Integration For Early Life-saving Detection)
This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program [Smart Health Integration for Early Life-saving Detection (SHIELD)] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy.
Infectious complications are among the most common, costly, and clinically consequential side effects experienced by patients receiving cancer-directed therapy and can lead to increased emergency department evaluations, reduced quality of life, and death.
National guidelines support using management strategies within cancer practices for selected patients with infectious complications; however, implementation remains limited by the need for reliable monitoring programs while the patient is at home.
The SHIELD program combines remote electronic patient-reported outcome symptom assessments with continuous temperature monitoring (CTM).
Patients complete electronic patient-reported outcome symptom assessments on a mobile application and wear a CTM device.
Patient responses and CTM data are integrated into the electronic health record, which can create alerts.
Cancer practice clinical assistants and nurses review the alerts and create care escalation pathways to the clinical care team or emergency department if needed.
The application can also deliver patient education and guidance for self-management of low-grade symptoms.
Using the SHIELD program in cancer practices may be an effective way to help manage infectious complications among cancer patients who are initiating systemic therapy.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
470
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Clinical Trials Referral Office
- 电话号码:855-776-0015
- 邮箱:mayocliniccancerstudies@mayo.edu
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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接触:
- Clinical Trials Referral Office
- 电话号码:855-776-0015
- 邮箱:mayocliniccancerstudies@mayo.edu
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首席研究员:
- Tufia C. Haddad, MD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Patient Inclusion Criteria, Aim 1:
- Documented history of cancer
- Actively receiving cancer care at any Mayo Clinic Midwest practice site
- Involved in or impacted by the care or participation of eligible patients
Patient Inclusion Criteria, Aim 2
- Documented diagnosis of cancer
- ≥ 1 year of age as the CTM device only supports these ages
- Initiating systemic cancer-directed treatment at a Mayo Clinic Midwest site
- Able to read and speak English or Spanish (or have a caregiver capable of either) as the current technologies only support those languages
Caregiver Inclusion Criteria
- Age 18 years or older.
- Identified as the eligible minor pediatric patient's parent or legal guardian
Healthcare Professional Inclusion Criteria
- A hematology/oncology clinical, research, RPM, operational, administrative, managerial, or technical/electronic health record (EHR) or other healthcare professional supporting or supervising, or directly affected by the SHIELD program development and pilot implementation study at a participating Mayo Clinic Health System site or Mayo Clinic in Rochester work unit.
Exclusion Criteria:
Patient Exclusion Criteria:
- History of hematopoietic cell transplant or adoptive cellular or bispecific antibody therapy [i.e., chimeric antigen receptor (CAR) T-cell (CAR-T)] within the prior 100 days
- Enrolled in hospice or expected life span < 6 months
Caregiver and Healthcare Professional Exclusion Criteria
- Unable or unwilling to provide consent to participate in study procedures
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Interview and group discussion (Aim 1)
Prior to program/intervention implementation, interviews and group discussions will be held with patients, caregivers, and hematology/oncology professional staff to determine who will benefit from SHIELD, whether the intended population can be reached, and whether SHIELD is perceived as appropriate for the patient population.
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实验性的:Aim 2 (SHIELD program)
Patients participate in the refined SHIELD program over 90 days and complete ePRO symptom assessments and wear a medical grade CTM device.
Patients may also receive care escalation to clinical care team or emergency services as needed as well as patient education and guidance for self-management of low-grade symptoms on study.
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Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
其他名称:
Patients complete questionnaires and study surveys
其他名称:
Smart Health Integration for Early Life-saving Detection (SHIELD) program used as an electronic patient-reported outcomes (ePRO) and continuous temperature monitoring (CTM)-integrated remote patient monitoring (RPM) care delivery model
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Reach - screening eligibility
大体时间:Baseline
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Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
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Baseline
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Reach - enrollment rates
大体时间:Baseline
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Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
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Baseline
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Reach - representativeness of enrollment
大体时间:Baseline
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Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
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Baseline
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Acceptability - PRISM PCSI Staff Survey
大体时间:Baseline
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The Practical Robust Implementation and Sustainability (PRISM) Contextual Survey Instrument (PCSI) staff survey consists of one question ascertaining the staff role and 29 questions related to perspectives, sustainability, and organizational characteristics of implementing the SHIELD remote patient monitoring program.
Questions are answered on a 5-point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree).
Results will be analyzed and reported descriptively.
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Baseline
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Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
大体时间:90 days
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The Remote Patient Monitoring (RPM) survey consists of 17 questions answered on a 5-point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) and two open-ended questions related to what impressed and what disappointed about the RPM program.
Results will be analyzed and reported descriptively.
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90 days
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Enrollment fidelity
大体时间:Baseline
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Assessed by staff-reported reasons for screening not being completed.
Results will be analyzed and reported descriptively.
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Baseline
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Intervention fidelity
大体时间:90 days
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Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention.
Results will be analyzed and reported descriptively.
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90 days
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Feasibility - treatment adherence
大体时间:90 days
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Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
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90 days
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Feasibility - symptoms recorded
大体时间:90 days
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Assessed by the percent overall of complete symptom data transmitted
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90 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Penetration - enrollment
大体时间:Baseline
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Assessed by the proportion of sites and individual work units who enroll patients
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月15日
初级完成 (估计的)
2031年6月30日
研究完成 (估计的)
2031年6月30日
研究注册日期
首次提交
2026年9月3日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.