Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment

NCT02232074 | Completed Results

• 3 other identifiers: H-32599RSG-13-368-01-CPPBAD-1304-6272
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership \| Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.

Conditions

Cancer

Keywords

Patient Navigation; Medical Legal Partnership; Healthcare Disparities

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants

  The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.

  Receipt of 1st treatment within 90 days from diagnosis

• Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants

  The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.

  Receipt of 1st treatment within 90 days from diagnosis

Secondary Outcomes (19)

• Distress Thermometer at 3 Months for BREAST Cancer Patients

  3 months after enrollment

• Distress Thermometer at 3 Months for LUNG Cancer Patients

  3 months after enrollment

• Distress Thermometer at 6 Months for BREAST Cancer Patients

  6 months after enrollment

• Distress Thermometer at 6 Months for LUNG Cancer Patients

  6 months after enrollment

• Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients

  6 months post-enrollment

Study Arms (2)

Patient navigation enhanced with legal support

EXPERIMENTAL

In addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers.

Other: Patient navigation enhanced with legal support

Standard patient navigation

NO INTERVENTION

These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs.

Interventions

Patient navigation enhanced with legal support OTHER

Patient navigation enhanced with legal support

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed breast and lung cancer patients
• Within 30 days of patient being informed of diagnosis
• Receiving cancer care at Boston Medical Center
• No history of cancer treatment in past 5 years
• No cognitive impairments
• Over 18 years of age
• Speak English, Spanish or Haitian Creole

You may not qualify if:

• Patient informed of cancer diagnosis \>30 days
• Patient under 18 yrs. of age
• Primary language something other than English, Spanish or Haitian Creole
• Undergoing treatment for concurrent cancer
• Patient has history of cancer or has received cancer treatment within the last 5 years
• Institutionalized/cognitive impairment (such as: dementia or metabolic, medication or drug induced), given the unique challenges to their treatment decision making/adherence and the fact that the intervention would not include the patient directly, but rather the family.

Sponsors & Collaborators

• Boston Medical Center: lead
• American Cancer Society, Inc.: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Tracy Battaglia
• Organization: Boston Medical Center

tracy.battaglia@bmc.org

617.638.8036

Study Officials

• Tracy A Battaglia, M.D., M.P.H

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Sharon Bak, M.P.H

  Boston Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 15, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)