Cancer Clinical Trial
Official title:
Advancing Palliative Care in Northern Plains American Indians: 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. .
Status | Recruiting |
Enrollment | 84 |
Est. completion date | August 31, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Walking Forward - Avera Research Institute | Rapid City | South Dakota |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Avera McKennan Hospital & University Health Center, South Dakota State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | WHA Intervention Fidelity | Adherence to protocol will be evaluated via semi-structured interviews with patients | Through study completion, an average of 1 year | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Hospital Admissions | Number of times patient is hospitalized overnight | Through study completion, an average of 1 year | |
Secondary | ER Visits | Number of separate trips to Emergency Room | Through study completion, an average of 1 year | |
Secondary | Telemedicine VIsits | Number of visits with a provider over video or phone call | Through study completion, an average of 1 year | |
Secondary | Home Visits (not related to study) | Number of home visits with a health care professional (not a wawokiya/study interventionist) | Through study completion, an average of 1 year | |
Secondary | Caregiver Quality of life | Change from baseline in caregiver-reported quality of life across 10 domains as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQOL). The CarGOQOL is a 29-item Likert scale (1-5). Scores range from 29- 145. Higher scores indicate a higher quality of life. | Through study completion, an average of 1 year | |
Secondary | Caregiver burden | Change from baseline in caregiver-reported burden measured by the Montgomery Borgatta Caregiving Burden (MBCB). The MBCB is a 14-item Likert scale (15) subdivided into 3 scales(objective burden, subjective stress burden, subjective demand burden). Scores on the objective subscale range from 6-30 and scores on the stress and demand burden subscales range from 4-20. Higher scores across sub scales indicate higher burden. | Through study completion, an average of 1 year | |
Secondary | Caregiver loneliness | Change from baseline in caregiver-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 | |
Secondary | Caregiver hope | Change from baseline in caregiver-reported hope as measured by Herth Hope Index (HHI). he 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 |
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