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

NCT05208606 | Completed

• 1 other identifier: 2021P003376
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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. .

Conditions

Cancer

Keywords

American Indians; Community Health Worker; Palliative Care; Native American; Navigation; Lay Health Worker; Cancer Navigation

Outcome Measures

Primary Outcomes (4)

• Cancer patient quality of life

  Change from baseline in patient-reported quality of life measured by the Functional Assessment of Cancer Therapy - General 7 (FACT-G7) through study completion (we anticipate an average of 1 year). FACT-G7 is a 7-item Likert scale (range 0-4). Scores range from 0-28, higher scores indicate better quality of life.

  Through study completion post baseline, an average of 1 year

• Cancer patient symptom burden

  Change from baseline in patient-reported symptom burden as measured by the Edmonton System Assessment System - revised (ESAS-r). The ESAS-r is a 9-item scale that measures a total of 9 symptoms on a continuous scale of 0 (no symptoms present) to 10 (most severe level). Scores range from 0-90. Higher scores indicated greater symptom burden.

  Through study completion post baseline, an average of 1 year

• Cancer patient loneliness

  Change from baseline in patient-reported loneliness as measured by the University of California-Los Angeles (UCLA) three-item loneliness scale. The UCLA loneliness scale is a 3-item likert scale (range 1-3). Scores range from 3-9. Higher scores indicate greater loneliness.

  Through study completion, an average of 1 year

• Cancer patient hope

  Change from baseline in patient-reported hope as measured by Herth Hope Index (HHI). The HHI is a 12-item Likert scale (1-4). Scores range from 12-28. Higher scores indicate higher levels of hope.

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Hospital Admissions

  Through study completion, an average of 1 year

• ER Visits

  Through study completion, an average of 1 year

• Telemedicine VIsits

  Through study completion, an average of 1 year

• Home Visits (not related to study)

  Through study completion, an average of 1 year

• Caregiver Quality of life

  Through study completion, an average of 1 year

Other Outcomes (1)

• WHA Intervention Fidelity

  Through study completion, an average of 1 year

Study Arms (2)

Wawokiya Health Advocate

EXPERIMENTAL

Patients and caregivers allocated to the Wawokiya Health Advocate arm will receive a palliative intervention consisting of regular needs assessments and home visits. After the first 2 visits, visits will occur bi-weekly, though a WHA may increase or decrease frequency of visits pending patient and caregiver needs and cancer status. The first two study visits will follow the same broad structure-structure of follow up visits will be flexible based on patient and caregiver needs. The location of study visits will vary and may include the local IHS site, cancer centers, and the patient's home depending on health status. Patients will be randomized to either receive home visits upon enrollment or be placed on a waitlist.

Behavioral: Wawokiya Health Advocate

Waitlist Arm

NO INTERVENTION

Patients enrolled into the waitlist group will not receive any additional services beyond what is available to them in their standard course of care. Patients randomized to the waitlist group will be asked to identify a primary caregiver upon enrollment. Data collection procedures will occur as described below. While on the waitlist, any services available for patients and their families will be according to the standards of their local providers and primary cancer providers.

Interventions

Wawokiya Health Advocate BEHAVIORAL

Study visits 1 and 2 will follow the same broad procedures. Subsequent visits will be structured around needs. WHAs will cover multiple domains of assessment utilizing a visit guide. Visit 1: Specific topics covered in this visit will include; 1) an explanation of palliative care, study, and WHA role and 2) mapping of providers/family/caregivers The WHA will arrange dates and times for future visits. Visit 2: Occurs 1 week after the first visit. WHAs will begin to assess patient needs utilizing a needs assessment tool. Specific topics covered will include: 1) Documentation of disease history 2) Needs assessment screen Following Visits: After visit 2, activities will be based on needs assessed. Activities may entail: 1) Review of palliative care and WHA role, 2) Assessment of needs, 3) Addressing needs 3) Exploring goals of care. We anticipate patients will receive an average of 2-3 WHA visits per month. Investigators will hold regular supervisory meetings with the WHA.

Also known as: Community Health Worker

Wawokiya Health Advocate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• Do not meet any of the above criteria
• Caregivers
• 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
• Do not meet any of the criteria above

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• South Dakota State University: collaborator
• Avera McKennan Hospital & University Health Center: collaborator

Study Sites (1)

Walking Forward - Avera Research Institute

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-In-Chief

Model Details: A novel model will be used in alignment with community feedback on study design. Patients will be allocated to the intervention arm as dictated by interventionist panel capacity. Patients will be added to a waitlist "control" arm as dictated by intervention arm capacity.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 26, 2022
• Study Start: February 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 12, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)