Patient Navigation to Improve Patient-Centered Cancer Care

Cancer Clinical Trial

Official title:

Patient Navigation to Improve Patient-Centered Cancer Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226405
• Other study ID #: 17-183
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 2, 2023

Study information

• Verified date: April 2020
• Source: Massachusetts General Hospital
• Contact: Emma Whited
• Phone: 617-724-1968
• Email: ewhited[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Patient Navigation Program
PN program improve access, timeliness and adherence with cancer treatment
• Usual Care
the standard of care provided by the institution

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence With Cancer Treatment	Adherence with cancer treatment will be measured as no-show rate to scheduled oncology appointments.	2 years
Primary	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	Health Related Quality Of Life	Health related quality of life measured via the validated Functional Assessment of Cancer Therapy - General (FACT-G).	2 years
Secondary	Overall Survival	Overall survival rate of the study population.	2 years
Secondary	Proportion Of Patients Enrolled In Clinical Trials	Proportion of participants in the study that enroll on a clinical trial.	2 years
Secondary	Overall Missed Health Care Visits	Number of scheduled health care visits missed by enrolled patients.	2 years
Secondary	Emergency Department Visits	Number of emergency department visits by enrolled patients.	2 years
Secondary	Unplanned Hospitalizations/Readmissions	Number of unplanned hospitalizations and/or readmissions by enrolled patients.	2 years
Secondary	Inpatient Hospitalization Length Of Stay.	Number of days enrolled patients spent as a hospitalized inpatient.	2 years
Secondary	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
Secondary	Patient Engagement In Care	Patient engagement in care will be measured using the validated Perceived Efficacy in Patient-Physician Interactions (PEPPI) metric.	2 years
Secondary	Patient's Financial Burden	Patient financial burden will be measured using the validated Comprehensive Score for Financial Toxicity (COST) instrument.	2 years
Secondary	Patient Satisfaction with Cancer Care	Patient satisfaction with cancer care to be measured using the validated Cancer-Related Care Survey.	2 years