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Home Hospital for Lymphoma

26. oktober 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Home Hospital for Lymphoma
Remote monitoring and home-based care designed for hospitalized patients with lymphoma

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
enrollment rate
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptabiliteten af ​​interventionen
Tidsramme: 1 år
Kvalitative acceptabilitetsvurderinger fra patienter, plejere og klinikere opnået via individuelle exit-interviews vedrørende accept (dvs. brugen, effektiviteten og relevansen af ​​interventionen) fra patienter, pårørende og klinikere. Interventionen vil blive anset for acceptabel, hvis ≥ 60 % af patienterne, pårørende og klinikere rapporterer, at interventionen var nyttig.
1 år
Rates of completion of daily vital signs
Tidsramme: 1 year
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
1 year
Rates of Adverse Events
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 1 year
Number of days the participant receives home hospital care through the home hospital program.
1 year
Number of home visits
Tidsramme: 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
Tidsramme: 1 year
Number of phone calls required per participants as well as the average duration of these calls.
1 year
Number of urgent visits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
The number of imaging studies obtained per participant during the Home Hospital admission.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2020

Primær færdiggørelse (Faktiske)

1. januar 2021

Studieafslutning (Faktiske)

30. januar 2021

Datoer for studieregistrering

Først indsendt

6. juni 2020

Først indsendt, der opfyldte QC-kriterier

8. juni 2020

Først opslået (Faktiske)

9. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19-613

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data can be shared no earlier than 1 year following the date of publication

IPD-delingsadgangskriterier

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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