Psychosocial Intervention in Latino Patients with Advanced Cancer

NCT03763032 | Completed DMC

• 1 other identifier: 17-1955.cc
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Palliative Care; Latino; Psychosocial Intervention; Patient Navigation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Process Measure Assessment

  Start of study to end of study, up to 12 months

Other Outcomes (6)

• FACT-G Quality of Life Assessment

  Start of study to end of study, up to 12 months

• Depression Assessment

  Start of study to end of study, up to 12 months

• Anxiety Assessment

  Start of study to end of study, up to 12 months

Study Arms (1)

Stepped Interventions

EXPERIMENTAL

Patient navigation intervention, plus various psychosocial interventions

Behavioral: Counseling

Interventions

Counseling BEHAVIORAL

The patient navigator will provide educational materials, assessments, and counseling to the patients

Stepped Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80218, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stacy Fischer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• David Bekelman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Because this is a pilot study, all participants will be receiving the same intervention and no blinding will take place.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: January 23, 2018
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)