Clinical trial NCT01695382: Apoyo Con Carino: Patient Navigation for Palliative Care
Official title: Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Palliative Care
Patient Navigation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2012-09-28
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Palliative Care Overall
timeFrame: 3 months after enrollment
measure: Evidence of Advance Care Planning
timeFrame: 6 months after enrollment
measure: Assesment of Pain Management
timeFrame: 3 months after enrollment
measure: Hospice Utilization
timeFrame: 46 months after enrollment
Secondary outcomes:
measure: Aggressiveness of Care at the End of Life
timeFrame: At month 46
measure: Change in Quality of Life
timeFrame: Baseline and 3 months after enrollment
Other outcomes:
Locations:
city: Alamosa
country: United States
facility: San Luis Valley Regional Medical Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Eagle
country: United States
facility: Shaw Cancer Center
state: Colorado
city: Glenwood Springs
country: United States
facility: Valley View Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stacy M Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fischer 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.