An interventional study of Counseling in Advanced Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-No exclusion criteria listed
Patient navigation intervention, plus various psychosocial interventions
Behavioral: Counseling
The patient navigator will provide educational materials, assessments, and counseling to the patients
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.
Time frame: 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.
Time frame: Start of study to end of study, up to 12 months
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.
Time frame: Start of study to end of study, up to 12 months
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.
Time frame: Start of study to end of study, up to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Start of study to end of study, up to 12 months
Hospital Assessments
Evaluate the frequency of hospitalizations or deaths through patient medical records
Time frame: Start of study to end of study, up to 12 months
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver