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Trial record 31 of 1363 for:    rural

Reducing Disparities in Rural Advanced Cancer Patients and Caregivers

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ClinicalTrials.gov Identifier: NCT03456596
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
VA Office of Research and Development
University of South Alabama
Spartanburg Regional Family Medicine
Information provided by (Responsible Party):
Marie Anne Bakitas, University of Alabama at Birmingham

Tracking Information
First Submitted Date December 18, 2017
First Posted Date March 7, 2018
Last Update Posted Date March 7, 2018
Actual Study Start Date July 1, 2013
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2018)
General Organization Index (GOI) Outcomes Measure [ Time Frame: 1 Yr Post Implementation ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reducing Disparities in Rural Advanced Cancer Patients and Caregivers
Official Title Reducing Disparities in Rural Advanced Cancer Patients and Caregivers
Brief 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. 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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Cancer
Intervention Other: ENABLE
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/Cohorts Institution
Community cancer centers implementing ENABLE
Intervention: Other: ENABLE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2018)
4
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria

• none

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03456596
Other Study ID Numbers X140522006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marie Anne Bakitas, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators
  • VA Office of Research and Development
  • University of South Alabama
  • Spartanburg Regional Family Medicine
Investigators Not Provided
PRS Account University of Alabama at Birmingham
Verification Date February 2018