Apoyo Con Carino: Patient Navigation for Palliative Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01695382|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy. In addition they will have 5 navigator initiated home visits to review the educational materials and help patients and families address barriers to palliative care through education, advocacy, and activation.
As per Arm description
No Intervention: Control
Participants randomized to the control arm of the study will receive a packet of written materials that are appropriate linguistically and written for individuals with low health literacy.
- Improvement in Palliative Care Overall [ Time Frame: 3 months after enrollment ]Patient Navigator and Process Measure will capture the less tangible benefits of a patient navigator and help understand the effects of the many activities of the navigator beyond the scope of the prescribed intervention. The questions incorporate aspects of self-efficacy and patient activation (key concepts that patient navigators help improve).
- Evidence of Advance Care Planning [ Time Frame: 6 months after enrollment ]Chart review to determine if there is an advance directive in the medical record and classification of the type of advance directive (Medical Durable Power of Attorney (MDPOA), Advance Directive (AD), Living Will)
- Assesment of Pain Management [ Time Frame: 3 months after enrollment ]Pain management will be assessed through patient interviews utilizing the Brief Pain Inventory (BPI). The BPI Long Form (BPI-LF) is a 32-item self-report instrument that assesses the severity and impact of pain in patients with chronic diseases, e.g. cancer.
- Hospice Utilization [ Time Frame: 46 months after enrollment ]Length of stay in hospice program in days. Data will be collected through follow up phone calls, medical records review, and death records review to determine date of admission into hospice program and date of discharge (through death or dis-enrollment)
- Aggressiveness of Care at the End of Life [ Time Frame: At month 46 ]For patients who have died within the follow up period this outcome assesses aggressiveness of care at the end of life using a composite measure comprised of the following: chemotherapy within 14 days of death no hospice hospice within 3 days of death
- Change in Quality of Life [ Time Frame: Baseline and 3 months after enrollment ]McGill Quality of Life questionnaire (MQOL) will be used at baseline and at 3 months after enrollment. The MQOL is specifically designed for a palliative care population, measuring whole-person concerns magnified by advanced life-limiting illness. It is short, reliable, repeatable, and can be used to determine changes in QOL of groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695382
|United States, Colorado|
|San Luis Valley Regional Medical Center|
|Alamosa, Colorado, United States, 81101|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Denver Health and Hospital Authority|
|Denver, Colorado, United States, 80202|
|Shaw Cancer Center|
|Eagle, Colorado, United States, 81632|
|Valley View Medical Center|
|Glenwood Springs, Colorado, United States, 81601|
|Principal Investigator:||Stacy M Fischer, MD||University of Colorado, Denver|