Remote Electronic Patient Monitoring in Gastrointestinal Cancer
調査の概要
詳細な説明
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
Exclusion Criteria:
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
研究計画
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:Remote Electronic Patient Monitoring
|
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings.
Patient information is displayed on a computer located at the medical institution.
Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate).
Data are transmitted from sensors to the patient's smart phone.
|
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 |
---|---|---|
The Feasibility of Remote Electronic Patient Monitoring Intervention
時間枠:4 weeks
|
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
|
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
時間枠:4 weeks
|
4 weeks
|
|
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
時間枠:4 weeks
|
4 weeks
|
|
Number of concerning issues identified per patient during study period
時間枠:4 weeks
|
4 weeks
|
|
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
時間枠:4 weeks
|
4 weeks
|
|
Number of intervention-triggered emails generated to the primary oncology team during study period
時間枠:4 weeks
|
4 weeks
|
|
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
時間枠:4 weeks
|
4 weeks
|
|
Acceptability of Remote Electronic Patient Monitoring Intervention
時間枠:4 weeks
|
Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
|
4 weeks
|
Patient-Reported Quality of Life
時間枠:2 weeks and 4 weeks
|
Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
|
2 weeks and 4 weeks
|
Patient-Reported Symptoms
時間枠:2 weeks and 4 weeks
|
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
|
2 weeks and 4 weeks
|
Patient-Reported Depression and Anxiety Symptoms
時間枠:2 weeks and 4 weeks
|
Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
|
2 weeks and 4 weeks
|
Health Care Utilization
時間枠:4 weeks
|
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
|
4 weeks
|
協力者と研究者
捜査官
- 主任研究者:Joseph Greer, MD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
消化器がんの臨床試験
-
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