Advanced Cancer
Conditions
Keywords
Palliative Care, Latino, Psychosocial Intervention, Patient Navigation
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.
Interventions
BEHAVIORALCounseling
The patient navigator will provide educational materials, assessments, and counseling to the patients
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.
Intervention model description
All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed