Vets Helping Vets Pilot Study

Study Overview
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Brief Summary
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The overall goal of this study is to evaluate the feasibility of a veteran patient navigator and social work counseling intervention in veterans with advanced stage cancer at the Denver VA Medical Center. This is a tiered intervention: patients first receive the veteran patient navigator component of the intervention, and then if additional patient needs are present they receive the social work counseling component of the intervention. The overall intervention will help veterans communicate their care preferences with their providers.This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Detailed Description
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Many patients with advanced cancer suffer from multiple symptoms including pain and fatigue and high rates of depression and anxiety. Many also experience end of life care that is inconsistent with their preferences. Recent studies of palliative care find that symptoms, depression, and end of life care quality improved in patients with advanced cancer with multidisciplinary, specialist palliative care compared to usual care. However, these palliative care interventions are personnel-intensive and require multiple specialist providers. Because of the costs and limited availability of specialist palliative care providers, these interventions cannot be spread to the large population of patients with advanced cancer. Thus, there is a need for scalable interventions to improve symptoms, depression, and end of life care in this patient population. Patient navigators, who often belong to the community they serve, have improved rates of cancer screening, follow up on abnormal diagnostic tests, and adherence to chemotherapy regimens. There has been increasing recognition that palliative care is an important part of patient navigation. However, to the best of our knowledge, there have been no studies outside our research program that have examined the effects of a peer navigation intervention to improve palliative care outcomes. While patient navigators hold promise for improving outcomes in patients with advanced cancer, both psychosocial care needs and documenting future care preferences and goals may be complex. Therefore, the proposed intervention will supplement veteran patient navigators with a social work psychosocial intervention. The goal of the proposed study is to evaluate the feasibility of a stepped care intervention including a veteran patient navigator and social worker.

Official Title
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Vets Helping Vets Pilot Study

Conditions
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Advanced Stage Cancer

Intervention / Treatment
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* Behavioral: Veteran Patient Navigator and Social Work Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (over 18 years of age) Patient has an oncology provider within the VA ECHCS English is patient's primary language Has a reliable telephone Diagnosis of cancer deemed as incurable by oncology provider Oncology provider answers no to the question, Would you be surprised if this patient dies in the next year? Exclusion Criteria: Already receiving specialist palliative care or receiving hospice care

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 108 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>All participants are enrolled into the intervention arm and receive the Veteran Patient Navigator and Social Work Intervention. | Behavioral: Veteran Patient Navigator and Social Work Intervention<br>* Each study participant will receive a veteran patient navigator intervention which consists of five study visits consisting of advance care planning, pain/symptom management, and education about hospice and palliative care. When clinically indicated, patients will be referred to a social work intervention providing psychosocial care and support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 1A. Examine intervention feasibility. | The intervention will be feasible if: A. The participation rate is above 40% and the retention rate is above 60%. | 1 year | 
| Aim 1B. Examine intervention feasibility. | The intervention will be feasible if: B. Oncology providers and patient participants find the intervention acceptable as defined by mean ratings of above somewhat useful/helpful/satisfied (i.e., above 3 on a 1 to 5 Likert scale, where 5 is extremely and 1 is not at all. | 1 year | 
| Aim 1C. Examine intervention feasibility. | The intervention will be feasible if: C. There is less than 10% missing data on patient-reported survey measures. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 2A. aTrack intervention process in order to improve the intervention | A. Determine patient flow through the intervention and adherence to the study protocol by tracking: a. number of visits | 1 year | 
| Aim 2Ab. Track intervention process in order to improve the intervention | A. Determine patient flow through the intervention and adherence to the study protocol by tracking: b. visit length | 1 year | 
| Aim 2Ac. Track intervention process in order to improve the intervention | A. Determine patient flow through the intervention and adherence to the study protocol by tracking: c problem addressed | 1 year | 
| Aim 2Ad. Track intervention process in order to improve the intervention | A. Determine patient flow through the intervention and adherence to the study protocol by tracking: d. who is seen by the social worker and why | 1 year | 
| Aim 2Ae. Track intervention process in order to improve the intervention | A. Determine patient flow through the intervention and adherence to the study protocol by tracking: e. adherence to the study protocol | 1 year | 
| Aim 2B. Track intervention process in order to improve the intervention | B. Understand patient and oncology provider reactions through qualitative interviews to the intervention to inform how to improve feasibility or helpfulness. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced stage cancer,, patient navigator,, social work