Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi": Wawokiya Health Advocate Intervention

Informed by a Community Advisory Board (CAB) and community assessments performed in the first phase of work funded through R01CA240080, this study will test a wawokiya (one who helps) health advocate (WHA)-based palliative care intervention that aims to improve the wellbeing of patients with cancer. In alignment with community guidance, patients will be allocated to an intervention arm or a waitlist arm as dictated by capacity. For those patients receiving the intervention, palliative care trained WHAs will perform regular home visits to assess the needs of patients seriously ill with cancer (as defined by a referring provider) and their caregivers, and work to address those needs using their training and identified community resources. The frequency of visits / calls will be determined based on level of need. The specific aims are listed below.

Specific Aim 1: To examine the impact of a wawokiya health advocate (WHA) palliative care intervention on patient health outcomes including quality of life, symptom burden, and psychosocial wellbeing.

H1: Compared to patients in the waitlist group, patients enrolled in the WHA intervention will have a better quality of life, greater psychosocial wellbeing, and lower symptom burden.

Specific Aim 2: To assess the impact of a WHA palliative care intervention on patient healthcare utilization including emergency room visits, hospitalizations, telehealth visits, and concordance of services with goals of care.

H2: Patients enrolled in the WHA intervention will have fewer ER visits and hospitalizations and a greater number of telehealth visits than patients enrolled in the waitlist group.

H3: A greater proportion of patients enrolled in the WHA intervention will die in their preferred location.

Specific Aim 3: To examine the impact of a WHA palliative care intervention on caregiver outcomes including coping, caregiver burden, and quality of life.

H4: Compared to caregivers in the waitlist group, caregivers enrolled in the WHA intervention will have a better quality of life, better coping, and decreased caregiver burden.

Specific Aim 4: To explore moderators and mediators of a WHA as a palliative care navigator on rural reservations in South Dakota.

H5: Adherence to protocols will moderate the effectiveness of a WHA as a PC navigator.

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One of the greatest areas of need in cancer care for American Indians in the Northern Plains is palliative care.Defined as the services needed to live well with serious illness, access to palliative care services by this population is almost non-existent, particularly in areas like western South Dakota where many tribal lands are located. Because of the distance to the nearest cancer care facility, the lack of transportation, and the lack of community-based palliative care, the great majority of American Indians with cancer living on Reservations are separated from their families during inpatient cancer care and die either alone in a hospital or at home suffering unnecessarily from symptoms such as pain, shortness of breath and anxiety. While this would be unacceptable for any group, it is particularly detrimental for Tribal Nations in the Northern Plains given the US governmental responsibility for providing their health care, the poverty experienced by the tribes, and the importance the people of these Nations place on spiritual preparation and community support at the end of life.

The past decade has witnessed substantial advances in the delivery of palliative care in other settings, particularly urban areas. Early application of palliative care services has been demonstrated to improve outcomes for patients with cancer, and new models of palliative care delivery are being developed, tested and implemented. Key features of these models, including the use of primary palliative care education, patient navigators and telemedicine for palliative care, have clear applications in the delivery of palliative care to American Indians in the Northern Plains.

Over the last 7 years, investigators have developed a multidisciplinary, Native-driven collaboration to advance the health of Lakota tribes that brings together multiple organizations in South Dakota (Great Plains Tribal Leaders Health Board \[GPTLHB\], Avera Health, Walking Forward, South Dakota State University School of Nursing, Indian Health Service \[IHS\]), the three largest tribes in western South Dakota (Cheyenne River, Oglala, and Rosebud Sioux tribes) and Mass General/Harvard. Initially developed to support clinical care for the Rosebud Sioux tribe, the Great Plains Lakota Health Research Collaboration (GPLHRC) has expanded to address critical health care issues affecting tribal communities across the region.

In the initial phase of the current project, the GPLHRC engaged with community members from each of the three tribes to better understand the existing palliative care landscape. We held 19 talking circles with cancer patients and their caregivers and conducted 12 interviews with local tribal leaders and traditional healers. In addition, we interviewed 38 health care providers both on and off the reservations. In holding open discourse with these key stakeholders, the GPLHRC identified many of the needs and concerns held within the South Dakota provider and patient community regarding palliative care for reservation-dwelling individuals and several challenges providers and their patients face to accessing and/or delivering palliative care.

Our work revealed that the fragmentation of services between the IHS and the urban or semi-urban cancer centers, as well different cultural backgrounds of providers and American Indian patients significantly influence the delivery of palliative services. The need for better coordination between providers and improved navigation of palliative care resources for patients was highlighted across the community. Additionally, providers expressed a desire for additional knowledge about Lakota culture as well as additional knowledge about existing resources and health infrastructure on the reservations.

Informed by Community Advisory Board (CAB) and the qualitative data described above, the investigators have developed a wawokiya health advocate (WHA)-based palliative care navigation intervention that aims to improve the wellbeing of patients with cancer. After receiving a specialized training curriculum through the Harvard Medical School Center for Palliative Care (HMS CPC), WHAs will make regular home visits to patients suffering from cancer to assess needs and locate resources to appropriately address the issues assessed. In alignment with community feedback, patients and their caregivers will be allocated to a waitlist group or the intervention as dictated by WHA patient panel capacity. By evaluating the impact of the intervention on patients and caregivers compared to usual oncologic care, investigators aim to provide evidence for the long-term implementation of a sustainable approach to palliative care delivery for Reservation-dwelling American Indians in the Northern Plains and generate data to improve the quality of cancer care in rural settings across the US.

Eligibility Criteria:
Patients

Inclusion Criteria:

* Age greater than or equal to 18 years old
* Carry an active invasive cancer diagnosis (other than non-melanoma skin cancer)
* Self-report as a member of a federally recognized tribe
* Reside on Pine Ridge, Rosebud, or Cheyenne River Indian Reservations or within the Contract Health Service Delivery Area of the Pine Ridge, Cheyenne River, or Rosebud IHS Service Unit
* Able to complete baseline surveys
* Able to provide informed consent
* A clinician responds "no" to the question: "Would it be a surprise if this person died in the next 12 months?"

Exclusion Criteria:

* Do not meet any of the above criteria

Caregivers

Inclusion Criteria:

* Are greater than or equal to 18 years old
* Reside in Pine Ridge, Rosebud, or Cheyenne River Indian Reservations or within the Contract Health Service Delivery Area of the Pine Ridge, Cheyenne River, or Rosebud IHS Service Unit
* Identified as caregiver by an enrolled patient;
* Caregiver will be defined as anyone who patients identify as a consistent source of physical, mental, emotional or spiritual support.
* Able to complete baseline survey
* Able to provide informed consent

Exclusion Criteria:

* Do not meet any of the criteria above