Care Transition Intervention for Hospitalized Patients With Advanced Cancer

NCT05142345 | Completed

• 1 other identifier: 21-501
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cancer; Follow-Up Care; Care Services, Home; Consultation, Remote; Advanced Cancer; Hospitalization; Care Transition Intervention

Outcome Measures

Primary Outcomes (1)

• Patients' Confidence in Managing their Health Condition using the Patient Activation Measure-13 (PAM-13)

  Compare change in the PAM-13 from baseline to 10-20 days post-discharge between study groups. The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.

  Baseline to 10-20 days after hospital discharge

Secondary Outcomes (3)

• Quality of Communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Communication subscale

  Up to 10-20 days after hospital discharge

• Symptom Burden using the Edmonton Symptom Assessment Scale (ESAS-r)

  Baseline to 10-20 days after hospital discharge

• Psychological Symptoms using the Patient Health Questionnaire-4 (PHQ-4)

  Baseline to 10-20 days after hospital discharge

Other Outcomes (1)

• 30-day Hospital Readmissions

  Up to 30 days after discharge

Study Arms (2)

CONTINUUM Intervention Post-Hospital Discharge

EXPERIMENTAL

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.

Other: CONTINUUM Intervention

Usual Care Post-Hospital Discharge

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

CONTINUUM Intervention 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.

CONTINUUM Intervention Post-Hospital Discharge

Usual Care OTHER

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

Usual Care Post-Hospital Discharge

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Conquer Cancer Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daniel E Lage, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 2, 2021
• Study Start: December 15, 2021
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

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)