- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208606
Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi": Wawokiya Health Advocate Intervention
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.
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Study Overview
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara J Purvis, MPH
- Phone Number: 3153851379
- Email: spurvis@mgh.harvard.edu
Study Contact Backup
- Name: Bethany-Rose Daubman, MD
- Email: bdaubman@mgh.harvard.edu
Study Locations
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Recruiting
- Walking Forward - Avera Research Institute
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Contact:
- Michele Sargent
- Phone Number: 605-755-2312
- Email: michele.sargent@avera.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wawokiya Health Advocate
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.
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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.
Other Names:
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No Intervention: Waitlist Arm
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer patient quality of life
Time Frame: Through study completion post baseline, an average of 1 year
|
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.
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Through study completion post baseline, an average of 1 year
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Cancer patient symptom burden
Time Frame: Through study completion post baseline, an average of 1 year
|
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.
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Through study completion post baseline, an average of 1 year
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Cancer patient loneliness
Time Frame: Through study completion, an average of 1 year
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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
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Cancer patient hope
Time Frame: Through study completion, an average of 1 year
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Admissions
Time Frame: Through study completion, an average of 1 year
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Number of times patient is hospitalized overnight
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Through study completion, an average of 1 year
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ER Visits
Time Frame: Through study completion, an average of 1 year
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Number of separate trips to Emergency Room
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Through study completion, an average of 1 year
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Telemedicine VIsits
Time Frame: Through study completion, an average of 1 year
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Number of visits with a provider over video or phone call
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Through study completion, an average of 1 year
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Home Visits (not related to study)
Time Frame: Through study completion, an average of 1 year
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Number of home visits with a health care professional (not a wawokiya/study interventionist)
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Through study completion, an average of 1 year
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Caregiver Quality of life
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Caregiver burden
Time Frame: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Caregiver loneliness
Time Frame: Through study completion, an average of 1 year
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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
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Caregiver hope
Time Frame: Through study completion, an average of 1 year
|
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.
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Through study completion, an average of 1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHA Intervention Fidelity
Time Frame: Through study completion, an average of 1 year
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Adherence to protocol will be evaluated via semi-structured interviews with patients
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Through study completion, an average of 1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021P003376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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