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Home Hospital for Lymphoma

26. oktober 2022 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Home Hospital for Lymphoma
Remote monitoring and home-based care designed for hospitalized patients with lymphoma

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Akseptabilitet av intervensjonen
Tidsramme: 1 år
Kvalitative akseptabilitetsvurderinger fra pasienter, omsorgspersoner og klinikere oppnådd via individuelle exit-intervjuer angående aksept (dvs. nytten, effektiviteten og relevansen av intervensjonen) fra pasienter, pårørende og klinikere. Intervensjonen vil bli ansett som akseptabel hvis ≥ 60 % av pasientene, pårørende og klinikere rapporterer at intervensjonen 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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2020

Primær fullføring (Faktiske)

1. januar 2021

Studiet fullført (Faktiske)

30. januar 2021

Datoer for studieregistrering

Først innsendt

6. juni 2020

Først innsendt som oppfylte QC-kriteriene

8. juni 2020

Først lagt ut (Faktiske)

9. juni 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. oktober 2022

Sist bekreftet

1. oktober 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 19-613

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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