Clinical trial NCT02616588: Vets Helping Vets Pilot Study
Official title: Vets Helping Vets Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Stage Cancer
Keywords: advanced stage cancer,
patient navigator,
social work
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2015-11-30
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 108
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aim 1A. Examine intervention feasibility.
timeFrame: 1 year
measure: Aim 1B. Examine intervention feasibility.
timeFrame: 1 year
measure: Aim 1C. Examine intervention feasibility.
timeFrame: 1 year
Secondary outcomes:
measure: Aim 2A. aTrack intervention process in order to improve the intervention
timeFrame: 1 year
measure: Aim 2Ab. Track intervention process in order to improve the intervention
timeFrame: 1 year
measure: Aim 2Ac. Track intervention process in order to improve the intervention
timeFrame: 1 year
measure: Aim 2Ad. Track intervention process in order to improve the intervention
timeFrame: 1 year
measure: Aim 2Ae. Track intervention process in order to improve the intervention
timeFrame: 1 year
measure: Aim 2B. Track intervention process in order to improve the intervention
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, CO
name: David Bekelman, MPH, MD
role: PRINCIPAL_INVESTIGATOR
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