Psychosocial Intervention in Latino Patients With Advanced Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Counseling

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80218
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Stacy Fischer, MD, University of Colorado, Denver; Principal Investigator: David Bekelman, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Patient Navigation; Palliative Care; Latino; Psychosocial Intervention
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 17-1955.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No