Care Transition Intervention for Hospitalized Patients With Advanced Cancer

NCT ID: NCT05142345

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2025-03-30

Brief Summary

This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.

Detailed Description

To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 54 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.

The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.

Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.

Participants are expected to be on the study for up to 40 days after hospital discharge.

It is anticipated that about 286 people will take part in this research study.

Conditions

Cancer; Follow-Up Care; Consultation, Remote; Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CONTINUUM Intervention Post-Hospital Discharge

Participants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care.

Group Type: EXPERIMENTAL

CONTINUUM Intervention

Intervention Type: OTHER

The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

Usual Care Post-Hospital Discharge

Participants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences. Participants will complete questionnaires about their cancer and care.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.

Interventions

CONTINUUM Intervention

The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

Intervention Type: OTHER

Usual Care

Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >= 18 years
• First unplanned admission since diagnosis of advanced cancer to to the oncology service at Massachusetts General Hospital (MGH) or the medicine service with oncology consultation
• Known diagnosis of advanced breast, thoracic, genitourinary, gastrointestinal cancers, sarcoma, or melanoma
• Receiving ongoing oncology care at MGH
• Verbal fluency in English
• Internet/wifi or telephone access
• Residing in Massachusetts at the time of hospital discharge

Exclusion Criteria

• Admitted electively
• Discharged to a location other than home or expired during admission
• Discharged with hospice services

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conquer Cancer Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel E Lage, MD, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel E Lage, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

21-501

Identifier Type: -

Identifier Source: org_study_id