Apoyo Con Carino: Patient Navigation for Palliative Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Colorado, Denver
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
First received: September 25, 2012
Last updated: December 9, 2015
Last verified: December 2015
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, we are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.

Condition Intervention
Behavioral: Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Improved Palliative Care Overall [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    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).

  • Advance Care Planning [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (MDPOA, AD, Living Will)

  • Pain management [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory. The BPI (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.

  • Hospice Utilization [ Time Frame: 46 months after enrollment ] [ Designated as safety issue: No ]
    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)

Secondary Outcome Measures:
  • Aggressiveness of Care at the End of Life [ Time Frame: At month 46 ] [ Designated as safety issue: No ]
    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

  • Quality of Life [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    McGill Quality of Life questionnaire 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.

Estimated Enrollment: 240
Study Start Date: August 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Navigation
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy. In addition they will have 5 navigator initiated home visits to review the educational materials and help patients and families address barriers to palliative care through education, advocacy, and activation.
Behavioral: Navigation
As per Arm description
No Intervention: Control
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy.

Detailed Description:
Our 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. Our 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. We hypothesize that our 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 we demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, we can disseminate the training and intervention to all patient navigators working with Latino cancer patients.

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695382

Contact: Stacy M Fischer, MD 303-724-2406 stacy.fischer@ucdenver.edu

United States, Colorado
San Luis Valley Regional Medical Center Active, not recruiting
Alamosa, Colorado, United States, 81101
University of Colorado Cancer Center Active, not recruiting
Aurora, Colorado, United States, 80045
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80202
Contact: Sonia Deutsch         
Principal Investigator: Sonia Okuyama, MD         
Shaw Cancer Center Not yet recruiting
Eagle, Colorado, United States, 81632
Contact: Regina Fink, RN PhD         
Principal Investigator: Regina Fink, RN PhD         
Valley View Medical Center Not yet recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Regina Fink, RN PhD         
Principal Investigator: Regina Fink, RN PhD         
Sponsors and Collaborators
University of Colorado, Denver
American Cancer Society, Inc.
Principal Investigator: Stacy M Fischer, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01695382     History of Changes
Other Study ID Numbers: 12-0592 
Study First Received: September 25, 2012
Last Updated: December 9, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Colorado, Denver:
Palliative Care
Patient Navigation

ClinicalTrials.gov processed this record on May 26, 2016