- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456596
Reducing Disparities in Rural Advanced Cancer Patients and Caregivers
Study Overview
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Rural serving community-based cancer centers that do not have a palliative care program
Exclusion Criteria
• none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Institution
Community cancer centers implementing 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Yr Post Implementation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on ENABLE
-
University of Alabama at BirminghamUniversity of South AlabamaRecruitingCancer Metastatic | Family MembersUnited States
-
Center for Disability Services, New YorkTufts University School of Dental MedicineCompletedOral HygieneUnited States
-
University of Alabama at BirminghamNational Palliative Care Research Center (NPCRC)CompletedHeart Failure, CongestiveUnited States
-
National Cancer Centre, SingaporeRecruiting
-
Belfast Health and Social Care TrustQueen's University, Belfast; Northern Ireland Clinical Trials UnitActive, not recruitingAcute Respiratory Failure With HypoxiaUnited Kingdom
-
Medtronic CardiovascularCompletedHeart Valve DiseasesUnited Kingdom, Austria, Switzerland, Poland, Germany
-
National Cancer Centre, SingaporeNational Medical Research Council (NMRC), Singapore; Ministry of Health, SingaporeActive, not recruiting
-
North Carolina State UniversityRecruitingLower Limb Amputation Below Knee (Injury)United States
-
University of Alabama at BirminghamUS Department of Veterans AffairsCompletedHeart FailureUnited States
-
Rush University Medical CenterUniversity of Illinois at Chicago; AllianceChicagoActive, not recruitingContraception | Family Planning | PostPartumUnited States