Apoyo Con Carino: Patient Navigation for Palliative Care

Cancer Clinical Trial

Official title:

Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695382
• Other study ID #: 12-0592
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: February 1, 2017
• Start date: August 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, the investigators are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.

Description:

This project uses a patient navigator to deliver a culturally tailored intervention to improve palliative care for Latinos with advanced cancer in urban and rural communities. The proposed research aims to improve palliative care with the goal of preventing and relieving suffering for people facing serious, complex illness. Palliative care, according to the National Quality Forum and Centers for Medicare and Medicaid, provides patient and family-centered care offered in conjunction with curative and all other appropriate forms of medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs, and facilitates patients' understanding of illness and choice. There is emerging evidence that palliative care may also improve survival for cancer patients. The proposed research also focuses on reducing health disparities. Studies have shown that Latinos are more likely to die in a hospital, less likely to use hospice services, and more likely to have unmanaged pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several rural communities (including some of the poorest, most underserved counties in Colorado). Patients will be randomized to either a control or intervention group. The control group will receive written materials covering three important palliative care domains -advance care planning, pain management, and hospice care. The materials, in English and Spanish, are appropriate for patients with low health literacy. Patients in the intervention group will receive the same written materials but will also have a patient navigator who will make 5 home visits to review materials, help patients and families talk about goals/values, and complete an advance directive, all in a culturally and linguistically appropriate manner. The navigator may also help with: accessing community resources, participating in family meetings with health care providers, and offering support to patients and families. The investigators hypothesize that the intervention will increase advance care planning, improve pain management, increase hospice referrals, and patients will have improved palliative care overall at the end of life. The patient navigator model has demonstrated an ability to improve cancer screening, early diagnosis, treatment, and survivorship. Once the investigators demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, they can disseminate the training and intervention to all patient navigators working with Latino cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Stage III or Stage IV cancer (all types)

• Self-identify as Latino

• 18 years of age or older

• Speak English or Spanish

Exclusion Criteria:

• Lacking decisional capacity

• Incarcerated

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Navigation
As per Arm description

Locations

Country	Name	City	State
United States	San Luis Valley Regional Medical Center	Alamosa	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Shaw Cancer Center	Eagle	Colorado
United States	Valley View Medical Center	Glenwood Springs	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Palliative Care Overall	Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).	3 months after enrollment
Primary	Evidence of Advance Care Planning	Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)	6 months after enrollment
Primary	Assesment of Pain Management	Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.	3 months after enrollment
Primary	Hospice Utilization	Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)	46 months after enrollment
Secondary	Aggressiveness of Care at the End of Life	For patients who have died within the follow up period this outcome assesses aggressiveness of care at the end of life using a composite measure comprised of the following: chemotherapy within 14 days of death no hospice hospice within 3 days of death	At month 46
Secondary	Change in Quality of Life	McGill Quality of Life questionnaire (MQOL) will be used at baseline and at 3 months after enrollment. The MQOL is specifically designed for a palliative care population, measuring whole-person concerns magnified by advanced life-limiting illness. It is short, reliable, repeatable, and can be used to determine changes in QOL of groups.	Baseline and 3 months after enrollment