Home Hospital for Lymphoma
26 oktober 2022 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
3
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
enrollment rate
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptans av interventionen
Tidsram: 1 år
|
Kvalitativa acceptansbetyg från patienter, vårdgivare och läkare erhållna via individuella utgångsintervjuer angående acceptans (dvs.
användbarheten, effektiviteten och relevansen av interventionen) från patienter, familjevårdare och läkare.
Interventionen kommer att anses vara acceptabel om ≥ 60 % av patienterna, familjevårdare och läkare rapporterar att interventionen var till hjälp.
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1 år
|
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Rates of completion of daily vital signs
Tidsram: 1 year
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Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
|
1 year
|
|
Rates of Adverse Events
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
Tidsram: 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.
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1 year
|
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Psychological distress (Hospital Anxiety and Depression Scale - HADS)
Tidsram: 1 year
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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)
Tidsram: 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.
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1 year
|
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Length of home hospital admission
Tidsram: 1 year
|
Number of days the participant receives home hospital care through the home hospital program.
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1 year
|
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Number of home visits
Tidsram: 1 year
|
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
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1 year
|
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Number of phone calls
Tidsram: 1 year
|
Number of phone calls required per participants as well as the average duration of these calls.
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1 year
|
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Number of urgent visits
Tidsram: 1 year
|
The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
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1 year
|
|
Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
Tidsram: 1 year
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The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
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1 year
|
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Number of hospital readmissions
Tidsram: 1 year
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The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
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1 year
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Number of imaging studies
Tidsram: 1 year
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The number of imaging studies obtained per participant during the Home Hospital admission.
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1 year
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2020
Primärt slutförande (Faktisk)
1 januari 2021
Avslutad studie (Faktisk)
30 januari 2021
Studieregistreringsdatum
Först inskickad
6 juni 2020
Först inskickad som uppfyllde QC-kriterierna
8 juni 2020
Första postat (Faktisk)
9 juni 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 oktober 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 oktober 2022
Senast verifierad
1 oktober 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 19-613
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data can be shared no earlier than 1 year following the date of publication
Kriterier för IPD Sharing Access
Contact the Partners Innovations team at http://www.partners.org/innovation
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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