CancerNCT01695382
Apoyo Con Carino: Patient Navigation for Palliative Care
A study testing Navigation in people with Cancer, run by University of Colorado, Denver at 5 sites in United States.
Trial summary
Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III or Stage IV cancer (all types)
- Self-identify as Latino
- 18 years of age or older
- Speak English or Spanish
Who cannot join
- Lacking decisional capacity
- Incarcerated
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
San Luis Valley Regional Medical Center
Alamosa, Colorado, 81101
University of Colorado Cancer Center
Aurora, Colorado, 80045
Denver Health and Hospital Authority
Denver, Colorado, 80202
Shaw Cancer Center
Eagle, Colorado, 81632
Valley View Medical Center
Glenwood Springs, Colorado, 81601
About this study
Official title: Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer
Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, the investigators are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.
Read the detailed description
This project uses a patient navigator to deliver a culturally tailored intervention to improve palliative care for Latinos with advanced cancer in urban and rural communities. The proposed research aims to improve palliative care with the goal of preventing and relieving suffering for people facing serious, complex illness. Palliative care, according to the National Quality Forum and Centers for Medicare and Medicaid, provides patient and family-centered care offered in conjunction with curative and all other appropriate forms of medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs, and facilitates patients' understanding of illness and choice. There is emerging evidence that palliative care may also improve survival for cancer patients. The proposed research also focuses on reducing health disparities. Studies have shown that Latinos are more likely to die in a hospital, less likely to use hospice services, and more likely to have unmanaged pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several rural communities (including some of the poorest, most underserved counties in Colorado). Patients will be randomized to either a control or intervention group. The control group will receive written materials covering three important palliative care domains -advance care planning, pain management, and hospice care. The materials, in English and Spanish, are appropriate for patients with low health literacy. Patients in the intervention group will receive the same written materials but will also have a patient navigator who will make 5 home visits to review materials, help patients and families talk about goals/values, and complete an advance directive, all in a culturally and linguistically appropriate manner. The navigator may also help with: accessing community resources, participating in family meetings with health care providers, and offering support to patients and families. The investigators hypothesize that the intervention will increase advance care planning, improve pain management, increase hospice referrals, and patients will have improved palliative care overall at the end of life. The patient navigator model has demonstrated an ability to improve cancer screening, early diagnosis, treatment, and survivorship. Once the investigators demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, they can disseminate the training and intervention to all patient navigators working with Latino cancer patients.
- Conditions
- Cancer
- Being tested
- Navigation
- Keywords
- Cancer, Palliative Care, Patient Navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
As per Arm description
| Study group | Role | What they receive |
|---|---|---|
| Navigation | Experimental | 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. Receives: Behavioral: Navigation |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Palliative Care Overall
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).
Measured: 3 months after enrollment
Evidence of Advance Care Planning
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)
Measured: 6 months after enrollment
Assesment of Pain Management
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.
Measured: 3 months after enrollment
Hospice Utilization
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)
Measured: 46 months after enrollment
Secondary outcomes (2)
Aggressiveness of Care at the End of Life
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
Measured: At month 46
Change in Quality of Life
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.
Measured: Baseline and 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Stacy M Fischer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695382
- Sponsor's protocol ID
- 12-0592
- Status last verified
- Feb 2017
- First submitted
- 25 Sep 2012
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fischer SM, Kline DM, Min SJ, Okuyama-Sasaki S, Fink RM. Effect of Apoyo con Carino (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1736-1741. doi: 10.1001/jamaoncol.2018.4014.
PubMed 30326035Fischer SM, Kline DM, Min SJ, Okuyama S, Fink RM. Apoyo con Carino: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial. J Natl Compr Canc Netw. 2017 Nov;15(11):1392-1399. doi: 10.6004/jnccn.2017.7005.
PubMed 29118231
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoyo Con Carino: Patient Navigation to Improve Palliative Care Outcomes for Latinos With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01695382
- Acronym / sponsor ID
- 12-0592
- Conditions
- Cancer
- Keywords
- Cancer, Palliative Care, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative care is a priority area of focus for health care in an aging population experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, the investigators are testing a patient navigator intervention to improve palliative care outcomes for Latinos with advanced cancer.
Detailed description
This project uses a patient navigator to deliver a culturally tailored intervention to improve palliative care for Latinos with advanced cancer in urban and rural communities. The proposed research aims to improve palliative care with the goal of preventing and relieving suffering for people facing serious, complex illness. Palliative care, according to the National Quality Forum and Centers for Medicare and Medicaid, provides patient and family-centered care offered in conjunction with curative and all other appropriate forms of medical treatment. It addresses physical, intellectual, emotional, social, spiritual needs, and facilitates patients' understanding of illness and choice. There is emerging evidence that palliative care may also improve survival for cancer patients. The proposed research also focuses on reducing health disparities. Studies have shown that Latinos are more likely to die in a hospital, less likely to use hospice services, and more likely to have unmanaged pain. This study will recruit 240 Latino patients with advanced cancer from an urban safety net hospital, a National Cancer Institute-designated Comprehensive Cancer Center, and several rural communities (including some of the poorest, most underserved counties in Colorado). Patients will be randomized to either a control or intervention group. The control group will receive written materials covering three important palliative care domains -advance care planning, pain management, and hospice care. The materials, in English and Spanish, are appropriate for patients with low health literacy. Patients in the intervention group will receive the same written materials but will also have a patient navigator who will make 5 home visits to review materials, help patients and families talk about goals/values, and complete an advance directive, all in a culturally and linguistically appropriate manner. The navigator may also help with: accessing community resources, participating in family meetings with health care providers, and offering support to patients and families. The investigators hypothesize that the intervention will increase advance care planning, improve pain management, increase hospice referrals, and patients will have improved palliative care overall at the end of life. The patient navigator model has demonstrated an ability to improve cancer screening, early diagnosis, treatment, and survivorship. Once the investigators demonstrate the efficacy of a patient navigator intervention to improve palliative care for advanced cancer patients, they can disseminate the training and intervention to all patient navigators working with Latino cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation | Experimental | Behavioral: NavigationParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage III or Stage IV cancer (all types)
- Self-identify as Latino
- 18 years of age or older
- Speak English or Spanish
Key exclusion criteria (2 listed)
- Lacking decisional capacity
- Incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigationAs per Arm description | Behavioural | Navigation |
Primary outcome
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)
2 secondary outcomes
Aggressiveness of Care at the End of Life
Time frame: At month 46
Change in Quality of Life
Time frame: Baseline and 3 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 30326035Fischer SM, Kline DM, Min SJ, Okuyama-Sasaki S, Fink RM. Effect of Apoyo con Carino (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1736-1741. doi: 10.1001/jamaoncol.2018.4014.
- Derived from this study: PubMed 29118231Fischer SM, Kline DM, Min SJ, Okuyama S, Fink RM. Apoyo con Carino: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial. J Natl Compr Canc Netw. 2017 Nov;15(11):1392-1399. doi: 10.6004/jnccn.2017.7005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy M Fischer, MD principal investigator
University of Colorado, Denver
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation in people with Cancer, run by University of Colorado, Denver at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Palliative Care Overall (time frame: 3 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.