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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
470
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究場所
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
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コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
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主任研究者：
- Tufia C. Haddad, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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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実験的：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
他の名前：
Patients complete questionnaires and study surveys
他の名前：
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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Reach - screening eligibility
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Penetration - enrollment
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月15日
一次修了 (推定)
2031年6月30日
研究の完了 (推定)
2031年6月30日
試験登録日
最初に提出
2026年9月3日
QC基準を満たした最初の提出物
2026年9月3日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。