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Completed

NCT Number: NCT03763032

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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