NCT03226405

Brief Summary

The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained community-based personnel to improve cancer care in underserved communities by increasing cancer screening and removing barriers to timely care. This program incorporate rigorous evaluation to demonstrate the impact of innovation in healthcare delivery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

July 19, 2017

Last Update Submit

April 20, 2020

Conditions

Keywords

Cancer

Outcome Measures

Primary Outcomes (2)

  • Adherence With Cancer Treatment

    Adherence with cancer treatment will be measured as no-show rate to scheduled oncology appointments.

    2 years

  • The Time From Cancer Diagnosis To First Oncology Appointment

    Length of time in days from cancer diagnosis to first completed oncology appointment.

    2 Years

Secondary Outcomes (11)

  • Health Related Quality Of Life

    2 years

  • Overall Survival

    2 years

  • Proportion Of Patients Enrolled In Clinical Trials

    2 years

  • Overall Missed Health Care Visits

    2 years

  • Emergency Department Visits

    2 years

  • +6 more secondary outcomes

Study Arms (2)

Patient Navigation Program

EXPERIMENTAL

* The study team will identify, track, and provide navigation for all adult patients referred to Cancer Center from the CHC and community partners for cancer treatment. * The Patient Navigation Program include * Education, * Appointment reminders, * Help with insurance, * Transportation, * Navigating the Cancer Center, * Assisting in finding appropriate child care, * Interpreting, * Connecting the patient to psychosocial and/or palliative care teams, * Physically escorting the patient to appointments

Other: Patient Navigation Program

Standard of Care

ACTIVE COMPARATOR

* The patients will receive enhanced usual care, * This consist of personal phone call reminders about upcoming appointments at the MGH Cancer Center

Other: Usual Care

Interventions

PN program improve access, timeliness and adherence with cancer treatment

Patient Navigation Program

the standard of care provided by the institution

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age 18 and older)
  • Newly diagnosed with cancer referred from Massachusetts General Hospital (MGH) community health centers in
  • Revere
  • Chelsea
  • Charlestown
  • surrounding communities referred to receive cancer treatment at the MGH Cancer Center

You may not qualify if:

  • Patients that primary care providers exclude

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Sanja Percac-Lima, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

November 1, 2017

Primary Completion

October 2, 2020

Study Completion

October 2, 2023

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations