Psychosocial Intervention in Latino Patients With Advanced Cancer

Study Overview
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Brief Summary
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Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.

Official Title
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Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients With Advanced Cancer

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ages > or = 18 years of age Must self-identify as Latino/a Have stage III/IV cancer Seeking or In treatment for their cancer (ie: not in hospice care) Not incarcerated Have at least moderate baseline distress (> 4 on the NCCN Distress Thermometer) or positive screen for depression (PHQ-2 score >=3) or anxiety (GAD-2 score >=3) Exclusion Criteria: -No exclusion criteria listed

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped Interventions<br>Patient navigation intervention, plus various psychosocial interventions | Behavioral: Counseling<br>* The patient navigator will provide educational materials, assessments, and counseling to the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Recruitment: number of patients that are eligible to participate | Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate. | Start of study to end of study, up to 12 months | 
| Feasibility of Completion: number of patients that complete the study | Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study. | Start of study to end of study, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process Measure Assessment | Use the Advance Care Planning Engagement Survey to assess Behavior. 9 item questionnaire based on Change Theory using a 6 point Likert scale. Total score is a mean of all items with a range of 1-6. | Start of study to end of study, up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Latino, Psychosocial Intervention, Patient Navigation