Psychosocial Intervention in Latino Patients With Advanced Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stepped Interventions Patient navigation intervention, plus various psychosocial interventions |
Behavioral: Counseling
The patient navigator will provide educational materials, assessments, and counseling to the patients
|
Outcome Measures
Primary Outcome Measures
- Feasibility of Recruitment: number of patients that are eligible to participate [Start of study to end of study, up to 12 months]
Assess how likely patients are to join the study through tracking the number of patients that are eligible to participate.
- Feasibility of Completion: number of patients that complete the study [Start of study to end of study, up to 12 months]
Assess how likely patients are to adhere to the study through tracking the number of patients that complete the study.
Secondary Outcome Measures
- Process Measure Assessment [Start of study to end of study, up to 12 months]
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.
Other Outcome Measures
- FACT-G Quality of Life Assessment [Start of study to end of study, up to 12 months]
Assess each patient's quality of life through the Function Assessment of Chronic Illness Therapy-General (FACT-G), which is a 27 question self-reporting measure of quality of life. Scale range is 0-108, higher scores indicating higher quality of life.
- Depression Assessment [Start of study to end of study, up to 12 months]
Use the Patient Health Questionnaire-8 to measure depressive symptoms through an 8 item assessment. Score ranges are 0-24, higher scores representing more depressive symptoms.
- Anxiety Assessment [Start of study to end of study, up to 12 months]
Use the Generalize Anxiety Disorder-7 to measure symptoms of anxiety through a 7 question assessment. Score range is 0-21, with increased scores representing higher levels of anxiety.
- Pain Assessment: PEG questionnaire [Start of study to end of study, up to 12 months]
The PEG questionnaire assesses pain intensity and interference on a numeric rating scale. Scale range of each of three items is 0-10. Total score is the mean of the three item scores.
- Symptom Severity Assessment [Start of study to end of study, up to 12 months]
Use the Edmonton Symptom Assessment Scale (ESAS-r) to assess symptom severity on a numeric rating scale. Score range for each of the 9 items is 0-10 with total score summary of all individual symptom items.
- Hospital Assessments [Start of study to end of study, up to 12 months]
Evaluate the frequency of hospitalizations or deaths through patient medical records
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults ages > or = 18 years of age
-
Must self-identify as Latino/a
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Have stage III/IV cancer
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Seeking or In treatment for their cancer (ie: not in hospice care)
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Not incarcerated
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado | Aurora | Colorado | United States | 80218 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Stacy Fischer, MD, University of Colorado, Denver
- Principal Investigator: David Bekelman, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-1955.cc