Apoyo Con Carino: Patient Navigation for Palliative Care
1 other identifier
interventional
223
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Aug 2012
Longer than P75 for not_applicable cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 25, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 3, 2017
February 1, 2017
4.3 years
September 25, 2012
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (2)
Aggressiveness of Care at the End of Life
At month 46
Change in Quality of Life
Baseline and 3 months after enrollment
Study Arms (2)
Navigation
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Stage III or Stage IV cancer (all types)
- Self-identify as Latino
- years of age or older
- Speak English or Spanish
You may not qualify if:
- Lacking decisional capacity
- Incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- American Cancer Society, Inc.collaborator
Study Sites (5)
San Luis Valley Regional Medical Center
Alamosa, Colorado, 81101, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Denver Health and Hospital Authority
Denver, Colorado, 80202, United States
Shaw Cancer Center
Eagle, Colorado, 81632, United States
Valley View Medical Center
Glenwood Springs, Colorado, 81601, United States
Related Publications (2)
Fischer SM, Kline DM, Min SJ, Okuyama-Sasaki S, Fink RM. Effect of Apoyo con Carino (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1736-1741. doi: 10.1001/jamaoncol.2018.4014.
PMID: 30326035DERIVEDFischer SM, Kline DM, Min SJ, Okuyama S, Fink RM. Apoyo con Carino: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial. J Natl Compr Canc Netw. 2017 Nov;15(11):1392-1399. doi: 10.6004/jnccn.2017.7005.
PMID: 29118231DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy M Fischer, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2012
First Posted
September 28, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 3, 2017
Record last verified: 2017-02