Psychosocial Intervention in Latino Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763032
• Other study ID #: 17-1955.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• Counseling
The patient navigator will provide educational materials, assessments, and counseling to the patients

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Hospital Assessments	Evaluate the frequency of hospitalizations or deaths through patient medical records	Start of study to end of study, up to 12 months
Primary	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
Primary	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	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