CancerNCT05208606
Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi": Wawokiya Health Advocate Intervention
A study testing Wawokiya Health Advocate in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Wawokiya Health Advocate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- A clinician responds "no" to the question: "Would it be a surprise if this person died in the next 12 months?"
- 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
Who cannot join
- Do not meet any of the above criteria
- Caregivers
- Do not meet any of the criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Walking Forward - Avera Research Institute
Rapid City, South Dakota, 57701
About this study
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.
Read more
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.
.
Read the 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.
- Conditions
- Cancer
- Being tested
- Wawokiya Health Advocate
- Keywords
- American Indians, Community Health Worker, Palliative Care, Native American, Navigation, Lay Health Worker, Cancer Navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wawokiya Health AdvocateBehavioural
Also called Community Health Worker
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Hospital Admissions
Number of times patient is hospitalized overnight
Measured: Through study completion, an average of 1 year
ER Visits
Number of separate trips to Emergency Room
Measured: Through study completion, an average of 1 year
Telemedicine VIsits
Number of visits with a provider over video or phone call
Measured: Through study completion, an average of 1 year
Home Visits (not related to study)
Number of home visits with a health care professional (not a wawokiya/study interventionist)
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Feb 2023
- Primary completion1 Mar 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Dakota State University, Avera McKennan Hospital & University Health Center
- Responsible party
- Principal investigator, Katrina Armstrong, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208606
- Sponsor's protocol ID
- 2021P003376
- Status last verified
- Jul 2023
- First submitted
- 28 Dec 2021
- Last updated
- 12 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with researchers who are not involved in this study.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Palliative Care in Northern Plains American Indians: Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi" - Wawokiya Health Advocate Intervention
- ClinicalTrials.gov ID
- NCT05208606
- Acronym / sponsor ID
- 2021P003376
- Conditions
- Cancer
- Keywords
- American Indians, Community Health Worker, Palliative Care, Native American, Navigation, Lay Health Worker, Cancer Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- South Dakota State University, Avera McKennan Hospital & University Health Center
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wawokiya Health Advocate | Experimental | Behavioral: Wawokiya Health AdvocatePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- Do not meet any of the above criteria
- Caregivers
- Do not meet any of the criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wawokiya Health AdvocateAlso: Community Health WorkerStudy 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. | Behavioural | Wawokiya Health Advocate |
Primary outcome
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.
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.
Cancer patient loneliness
Time frame: Through study completion, an average of 1 year
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.
Cancer patient hope
Time frame: Through study completion, an average of 1 year
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.
8 secondary outcomes
Hospital Admissions
Time frame: Through study completion, an average of 1 year
ER Visits
Time frame: Through study completion, an average of 1 year
Telemedicine VIsits
Time frame: Through study completion, an average of 1 year
Home Visits (not related to study)
Time frame: Through study completion, an average of 1 year
Caregiver Quality of life
Time frame: Through study completion, an average of 1 year
Caregiver burden
Time frame: Through study completion, an average of 1 year
Caregiver loneliness
Time frame: Through study completion, an average of 1 year
Caregiver hope
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2025.
- Individual participant dataSharing planned: No. IPD will not be shared with researchers who are not involved in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wawokiya Health Advocate in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer patient quality of life (time frame: Through study completion post baseline, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2025.