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CancerNCT03456596

Reducing Disparities in Rural Advanced Cancer Patients and Caregivers

An observational study of Cancer, run by University of Alabama at Birmingham.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Purpose of this project is to implement ENABLE (Educate, Nurture, Advise, Before Life Ends) at four community cancer practices that have a high percentage of rural and/or medically-underserved patients diagnosed with advanced cancer and their family caregivers. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer
What is being tested?
ENABLE
How many people
4 participants
Where
No sites listed yet
Study dates
1 Jul 2013to 30 Jun 2017
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population is rural community-based cancer centers. According to the 2010 US Census data, nearly 60 million citizens live in rural or non-metropolitan areas;however, less than 10% of the 833 US palliative care programs are located in rural areas. Rural advanced cancer patients are vulnerable and at high risk of experiencing social isolation and disparities in palliative care due to long distances from treatment centers,low population density, and limited clinical expertise. Rural location is related to less and later hospice use.Hence, most rural cancer patients are unlikely to have access to interdisciplinary team-based palliative and hospice care recommended by ASCO and National Comprehensive Cancer Network guidelines.

Who may be able to join

  • Rural serving community-based cancer centers that do not have a palliative care program

Who cannot join

  • none

About this study

The Purpose of this project is to implement ENABLE (Educate, Nurture, Advise, Before Life Ends) at four community cancer practices that have a high percentage of rural and/or medically-underserved patients diagnosed with advanced cancer and their family caregivers. The ENABLE principal investigator (PI) and the Coordinating Center team are located at the University of Alabama at Birmingham (UAB). Site teams are - Spartanburg SC/Gibbs Cancer Center, Birmingham VA Medical Center, University of South Alabama/Mitchell Cancer Institute, UAB Division of Gynecologic Oncology and UAB Department of Hematology Oncology.

Read the detailed description

ENABLE is an evidence-based concurrent oncology palliative care model that is ready for implementation. It can overcome the barriers created by rural geography and addresses the often unrecognized and unmet needs of the family caregivers. The EIT is an emerging conceptual model for translating evidence into practice. The central core is the linkage between evidence and stakeholders. Successful implementation results from the interaction of Intervention Program/Policy (ENABLE), Implementation Processes (community-based participatory research methods[CBPR] within a learning collaborative) and the Practical Progress Measures (RE-AIM). On-going consideration of the Multi-level Context is pivotal to successful implementation. This approach has the potential to have a high impact on reducing disparities resulting from the gap between ASCO recommendations and current oncology and palliative care practices in rural patients and families.

The Urgent Need to Improve Rural Palliative and End-of-life Care for Patients and Caregivers According to the 2010 US Census data, nearly 60 million citizens live in rural or non-metropolitan areas; however, less than 10% of the 833 US palliative care programs are located in rural areas (data provided by the Center to Advance Palliative Care Registry). Rural advanced cancer patients are vulnerable and at high risk of experiencing social isolation and disparities in palliative care due to long distances from treatment centers, low population density, and limited clinical expertise (because rural primary care clinicians and hospices programs have relatively few terminally-ill patients.) Rural location is related to less and later hospice use. Hence, most rural cancer patients are unlikely to have access to interdisciplinary team-based palliative and hospice care recommended by ASCO2 and National Comprehensive Cancer Network guidelines. These patients will lack this expertise or be transferred to a distant site for palliation.6 Patients transferred to distant tertiary care settings are at high risk of spending their last days or weeks of life far from home and loved ones. Conversely, rural patients may suffer during their last weeks or days of life without the benefit of state-of-art treatments of pain or other causes of distress. A US palliative care report card identified rural location as high risk for little access to palliative care. By definition, palliative care includes family caregiver support. An estimated million Americans are informal caregivers defined as an unpaid individual who assist someone with functional impairment with activities of their daily living to some degree. Informal caregiving can have deleterious effects on the caregivers' physical and emotional health; a phenomenon referred to as caregiver burden. A recent meta- analysis showed that cancer caregivers in particular, compared to non-caregiver controls, exhibited higher levels of stress and depression, and lower subjective well-being and physical health. ENABLE includes the evidence-based, caregiver-specific COPE (Creativity, Optimism, Planning, Expert information) intervention, developed by McMillan and colleagues. COPE, based in problem-solving education theory, is designed to improve caregivers' creative problem-solving, realistic optimism, reasonable goal-setting, and knowledge/utilization of relevant resources. Compared to usual care, two weeks post-intervention, caregivers in COPE showed improvements in caregiver burden and overall QOL. COPE is the basis of the ACS caregiving guide and has been adapted for caregivers in other diseases.

Conditions
Cancer
Being tested
ENABLE
Keywords
CBPR, RE-AIM
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENABLEOther

    This is an implementation science study in which an evidence-based early palliative care intervention, ENABLE (Educate, Nurture, Advise, Before Life Ends), is being implemented in rural community cancer centers that did not have a palliative care program.

Study groups in NCT03456596
Study groupRoleWhat they receive
InstitutionCommunity cancer centers implementing ENABLE
Receives: Other: ENABLE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General Organization Index (GOI) Outcomes Measure

    The General Organizational Index (GOI) is used to describe the organizational strengths of an organization serving healthcare. The total range of the score would be 12 (lowest - no implementation of good organizational structure) to 60 (full implemented organizational structure). The score is derived from 12 categories which are assigned a score of 1 (no implementation) to 5 (fully implemented); hence a total possible score of 12 - 60.

    Measured: 1 Yr Post Implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start1 Jul 2013
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456596
Sponsor's protocol ID
X140522006
Status last verified
Feb 2018
First submitted
18 Dec 2017
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by University of Alabama at Birmingham.

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 1 inclusion and 1 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

General Organization Index (GOI) Outcomes Measure (time frame: 1 Yr Post Implementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Mar 2018.

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