Home Hospital for Lymphoma
2022年10月26日 更新者：El-Jawahri, Areej,M.D.、Massachusetts General Hospital
Supportive Oncology Care at Home Intervention for Patients With Lymphoma
The goal of this research is to evaluate an intervention, which the investigators call "Home Hospital for Lymphoma," that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at Massachusetts General Hospital.
調査の概要
詳細な説明
This research study is a single arm pilot Feasibility Study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the Home Hospital for Lymphoma program.
Participants will include 3 groups:
Enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians.
Participants will be in the research study for about six months after consent. It is expected that up to 38 participants will take part in this research study.
研究の種類
介入
入学 (実際)
3
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。
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital Cancer Center
-
-
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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 18 or older
- Receiving their lymphoma care with curative intent at MGH (treatment intent based upon chemotherapy order in the electronic medical record)
- Hemodynamically stable during the first 24 hours of hospital admission at MGH
- Residing within the designated geographic area for MGH Home Hospital Service (an approximately 10-mile radius from MGH)
- Able to communicate and respond to questionnaires in English
- Lives with a family member or a friend who supports the patient at home
- Deemed eligible for supportive oncology care at home based on the MGH Home Hospital clinician evaluation
Exclusion Criteria:
- Those admitted to the intensive care unit
- Have high oxygen requirement (FIO2 > 0.4)
- Experience active angina or cardiac arrythmias
- Have a planned inpatient surgical or interventional procedure
- Have uncontrolled psychiatric illness or impaired cognition that prohibits complying with the study procedures
- Have uncontrolled pain requiring intravenous pain medications
- Those deemed ineligible based on the Home Hospital Service clinician evaluation
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：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：Home Hospital for Lymphoma
The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
|
Remote monitoring and home-based care designed for hospitalized patients with lymphoma
|
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 |
|---|---|---|
|
enrollment rate
時間枠：1 year
|
The primary endpoint is feasibility.
The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study
|
1 year
|
|
retention rate
時間枠：1 year
|
The primary endpoint is feasibility.
The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
介入の受容性
時間枠：1年
|
患者、介護者、および臨床医から得られた受容性に関する定性的受容性評価 (すなわち、
介入の有用性、有効性、および関連性）を患者、家族介護者、および臨床医から。
患者、家族介護者、および臨床医の 60% 以上が介入が役に立ったと報告した場合、介入は許容可能と見なされます。
|
1年
|
|
Rates of completion of daily vital signs
時間枠：1 year
|
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
|
1 year
|
|
Rates of Adverse Events
時間枠：1 year
|
The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.
|
1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
時間枠：1 year
|
Change in participants' symptom burden as measured by the ESAS-r throughout the study.
The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.
|
1 year
|
|
Psychological distress (Hospital Anxiety and Depression Scale - HADS)
時間枠：1 year
|
Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.
|
1 year
|
|
Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
時間枠：1 year
|
Change in quality of life as measured by the FACT-G throughout the study, with range of 0-108 and higher scores indicating better quality of life.
|
1 year
|
|
Length of home hospital admission
時間枠：1 year
|
Number of days the participant receives home hospital care through the home hospital program.
|
1 year
|
|
Number of home visits
時間枠：1 year
|
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
|
1 year
|
|
Number of phone calls
時間枠：1 year
|
Number of phone calls required per participants as well as the average duration of these calls.
|
1 year
|
|
Number of urgent visits
時間枠：1 year
|
The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
|
1 year
|
|
Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
時間枠：1 year
|
The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
|
1 year
|
|
Number of hospital readmissions
時間枠：1 year
|
The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
|
1 year
|
|
Number of imaging studies
時間枠：1 year
|
The number of imaging studies obtained per participant during the Home Hospital admission.
|
1 year
|
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。
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 (実際)
2020年6月1日
一次修了 (実際)
2021年1月1日
研究の完了 (実際)
2021年1月30日
試験登録日
最初に提出
2020年6月6日
QC基準を満たした最初の提出物
2020年6月8日
最初の投稿 (実際)
2020年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2022年10月28日
QC基準を満たした最後の更新が送信されました
2022年10月26日
最終確認日
2022年10月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 19-613
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?
はい
IPD プランの説明
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Requests may be directed to: [contact information for Sponsor Investigator or designee].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共有時間枠
Data can be shared no earlier than 1 year following the date of publication
IPD 共有アクセス基準
Contact the Partners Innovations team at http://www.partners.org/innovation
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。
Home Hospital for Lymphomaの臨床試験
-
Nordsjaellands HospitalUniversity of Southern Denmark; Innovation Fund Denmark完了
-
Villanova UniversityUniversity of Pennsylvania; Thomas Jefferson University; Drexel University; Louisiana State University...募集
-
University of StavangerHelse Stavanger HF; St. Olavs Hospital積極的、募集していない
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)完了