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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Interventions | Experimental | Patient navigation intervention, plus various psychosocial interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | The patient navigator will provide educational materials, assessments, and counseling to the patients |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FACT-G Quality of Life Assessment | 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. | Start of study to end of study, up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
-No exclusion criteria listed
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| Name | Affiliation | Role |
|---|---|---|
| Stacy Fischer, MD | University of Colorado, Denver | Principal Investigator |
| David Bekelman, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80218 | United States |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
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Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.
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| Depression Assessment |
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. |
| Start of study to end of study, up to 12 months |
| Anxiety Assessment | 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. | Start of study to end of study, up to 12 months |
| Pain Assessment: PEG questionnaire | 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. | Start of study to end of study, up to 12 months |
| Symptom Severity Assessment | 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. | Start of study to end of study, up to 12 months |
| Hospital Assessments | Evaluate the frequency of hospitalizations or deaths through patient medical records | Start of study to end of study, up to 12 months |
| D005159 | Health Care Facilities Workforce and Services |