Patient Navigation to Improve Patient-Centered Cancer Care

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Patient Navigation Program; Other: Usual Care

Detailed Description

This program allow cancer patients from MGH Community Health Centers (CHC) and surrounding communities who experience barriers to accessing care, including poverty, and limited English proficiency, and provide them navigation to receive timely, guideline-concordant treatment at MGH Cancer Center. By offering these vulnerable individuals a patient-centered approach to treatment, The investigators aim to promote patient engagement and increase access throughout the continuum of cancer care.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Whited; Phone Number: 617-724-1968; Email: ewhited@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Emma Whited; Phone Number: 617-724-1968; Email: ewhited@mgh.harvard.edu
      • Principal Investigator: Sanja Percac-Lima, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-Patients that primary care providers exclude

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Navigation Program; 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 includeEducation,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; PN program improve access, timeliness and adherence with cancer treatment
Active Comparator: Standard of Care; 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; the standard of care provided by the institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality Of Life	Health related quality of life measured via the validated Functional Assessment of Cancer Therapy - General (FACT-G).	2 years
Overall Survival	Overall survival rate of the study population.	2 years
Proportion Of Patients Enrolled In Clinical Trials	Proportion of participants in the study that enroll on a clinical trial.	2 years
Overall Missed Health Care Visits	Number of scheduled health care visits missed by enrolled patients.	2 years
Emergency Department Visits	Number of emergency department visits by enrolled patients.	2 years
Unplanned Hospitalizations/Readmissions	Number of unplanned hospitalizations and/or readmissions by enrolled patients.	2 years
Inpatient Hospitalization Length Of Stay.	Number of days enrolled patients spent as a hospitalized inpatient.	2 years
Patient Satisfaction With Patient Navigation Program (PNP)	Patient satisfaction with patient navigation program (PNP) to be measured via the validated Patient Satisfaction with Navigation - 1 (PSN-1).	2 years
Patient Engagement In Care	Patient engagement in care will be measured using the validated Perceived Efficacy in Patient-Physician Interactions (PEPPI) metric.	2 years
Patient's Financial Burden	Patient financial burden will be measured using the validated Comprehensive Score for Financial Toxicity (COST) instrument.	2 years
Patient Satisfaction with Cancer Care	Patient satisfaction with cancer care to be measured using the validated Cancer-Related Care Survey.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Sanja Percac-Lima, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): October 2, 2020
• Study Completion (Anticipated): October 2, 2023

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: 17-183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No