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NCT05208606 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT05208606: Completed NA study, sponsored by Massachusetts General Hospital.

NCT05208606 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05208606, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study 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 WH

Primary Outcome

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.

Interventions

  • BEHAVIORAL Wawokiya Health Advocate

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2023-02-01
Est. Completion 2024-12-31
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT05208606 record still lists

NCT05208606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Wawokiya Health Advocate is the first listed.

NCT05208606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05208606 about?

NCT05208606 is a clinical study titled "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....

What is the current status of trial NCT05208606?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2023-02-01. Estimated completion is 2024-12-31.

What interventions are being tested in trial NCT05208606?

The interventions under investigation include: Wawokiya Health Advocate (BEHAVIORAL).

Who is sponsoring clinical trial NCT05208606?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05208606's enrollment target sits among peer trials

44 1423rd of 2000 higher than 566 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05208606, the US trial registry maintained by the National Library of Medicine. NCT05208606 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.