Hospital at Home at EOL in Heme Malignancies

NCT04690205 | Completed DMC

• 1 other identifier: 20-468
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.

Conditions

Hematologic Malignancy

Keywords

Hematologic Malignancy; Home Care Services

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate

  The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% (95% confidence interval +/- 18%) of eligible patients are enrolled in the study.

  6 months

• Retention Rate

  The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 80% of enrolled participants will complete a minimum of 60% of their daily assessments (i.e. patient-reported symptoms)

  6 months

Secondary Outcomes (9)

• Acceptability of the intervention

  6 months

• Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)

  up to 6 months

• Caregiver Quality of Life (CareGiver Oncology QOL)

  6 months

• Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)

  up to 6 months

• Caregiver Burden

  up to 6 months

Study Arms (1)

End of Life (EOL) Care at at Home

EXPERIMENTAL

End of Life (EOL) Care at at Home intervention entails the following: patient-reported symptoms and home monitored vital signs and body weight 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.

Other: End of Life (EOL) Care at at Home

Interventions

End of Life (EOL) Care at at Home OTHER

Remote monitoring and home-based care designed for patients with advanced hematologic malignancies

End of Life (EOL) Care at at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• diagnosed with relapsed or refractory hematologic malignancy
• must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
• deemed eligible to receive EOL care at home based on the primary oncologist's assessment
• Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
• residing within 50 miles of MGH. Of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate.

You may not qualify if:

• Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medically Home: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Nipp RD, Shulman E, Smith M, Brown PMC, Johnson PC, Gaufberg E, Vyas C, Qian CL, Neckermann I, Hornstein SB, Reynolds MJ, Greer J, Temel JS, El-Jawahri A. Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer. BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z.

  PMID: 35397575 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Death Domain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Death Domain Superfamily; Protein Interaction Domains and Motifs; Protein Domains; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 30, 2020
• Study Start: February 26, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)