Psychosocial Intervention in Latino Patients With Advanced Cancer

• ClinicalTrials.gov Identifier: NCT03763032
• Recruitment Status: Active, not recruiting
• First Posted: December 4, 2018
• Last Update Posted: August 19, 2021
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

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
Advanced Cancer	Behavioral: Counseling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
• Masking: None (Open Label)
• Masking Description: Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.
• Primary Purpose: Supportive Care
• Official Title: Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients With Advanced Cancer
• Actual Study Start Date: January 23, 2018
• Actual Primary Completion Date: July 31, 2018
• Estimated Study Completion Date: July 2022

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 :

1. Feasibility of Recruitment: number of patients that are eligible to participate [ Time Frame: 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.
2. Feasibility of Completion: number of patients that complete the study [ Time Frame: 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 :

1. Process Measure Assessment [ Time Frame: 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:

1. FACT-G Quality of Life Assessment [ Time Frame: 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.
2. Depression Assessment [ Time Frame: 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.
3. Anxiety Assessment [ Time Frame: 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.
4. Pain Assessment: PEG questionnaire [ Time Frame: 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.
5. Symptom Severity Assessment [ Time Frame: 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.
6. Hospital Assessments [ Time Frame: Start of study to end of study, up to 12 months ]
   Evaluate the frequency of hospitalizations or deaths through patient medical records

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Colorado

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

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03763032
• Other Study ID Numbers: 17-1955.cc
• First Posted: December 4, 2018
• Last Update Posted: August 19, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

Palliative Care; Latino; Psychosocial Intervention; Patient Navigation

Additional relevant MeSH terms:

Neoplasms