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Health Advocate Intervention for Cancer

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients:

Carry an active invasive cancer diagnosis (other than non-melanoma skin cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test if a palliative care-trained health advocate (WHA) can improve quality of life, symptom burden, and psychosocial wellbeing of cancer patients, and reduce ER visits, hospitalizations and ensure care is aligned with patient goals. It will also assess the impact on caregivers.

Who is the study for?

This trial is for adults over 18 living on Pine Ridge, Rosebud, or Cheyenne River Indian Reservations with an active invasive cancer diagnosis. Participants must be tribal members able to complete surveys and provide consent, have a caregiver, and not be expected to die within the next year.Check my eligibility

What is being tested?

The study tests a palliative care intervention by health advocates (WHAs) who visit homes of seriously ill cancer patients to improve their quality of life and wellbeing. Patients are either in the immediate intervention group or on a waitlist due to capacity limits.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like home visits from trained health advocates rather than drugs or medical procedures, traditional side effects are not applicable. However, there may be emotional impacts related to discussing palliative care needs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a patient seeking treatment.

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I have an active cancer diagnosis that is not non-melanoma skin cancer.

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I am 18 years old or older.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cancer patient hope

Cancer patient loneliness

Cancer patient quality of life

+1 more

Secondary outcome measures

Caregiver Quality of life

Caregiver burden

Caregiver hope

+5 more

Other outcome measures

WHA Intervention Fidelity

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Wawokiya Health AdvocateExperimental Treatment1 Intervention

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.

Group II: Waitlist ArmActive Control1 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,557 Total Patients Enrolled

South Dakota State UniversityOTHER

19 Previous Clinical Trials

9,962 Total Patients Enrolled

Avera McKennan Hospital & University Health CenterOTHER

34 Previous Clinical Trials

29,103 Total Patients Enrolled

Media Library

Wawokiya Health Advocate Clinical Trial Eligibility Overview. Trial Name: NCT05208606 — N/A

Cancer Research Study Groups: Wawokiya Health Advocate, Waitlist Arm

Cancer Clinical Trial 2023: Wawokiya Health Advocate Highlights & Side Effects. Trial Name: NCT05208606 — N/A

Wawokiya Health Advocate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05208606 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participation in this endeavor?

"Yes, according to clinicaltrials.gov this study is currently accepting participants for enrollment. The trial was initially published on February 1st 2023 and its details were most recently revised on July 14th 2023; the research team needs 84 individuals from a single location."

Answered by AI

What is the current sample size for this medical research?

"Affirmative, the information on clinicaltrials.gov implies that this medical trial is currently accepting volunteers. It was first debuted on February 1st 2023 and revised for the final time on July 14th of the same year. At present there are 84 prospective participants being sought out from a single research facility."

Answered by AI

What are the fundamental aims of this clinical trial?

"Measuring the quality of life experienced by cancer patients is this clinical trial's primary goal, and it will be tracked over a timespan of approximately one year. Additional secondary outcomes include hope as measured by Herth Hope Index (HHI), caregiver burden according to Montgomery Borgatta Caregiving Burden (MBCB), and hospital admissions per patient. The HHI consists of 12 items rated on a Likert scale from 1-4, with higher scores reflecting greater levels of hope; meanwhile, MBCB comprises 3 sub scales for objective burden, subjective stress burden and subjective demand burden that range from 6-30 for the former"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Katrina Armstrong, M.D. 2023. "Living Well With Serious Illness "Wicokuje Sica Tuha Akisniya Wiconi": Wawokiya Health Advocate Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208606.