- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464188
An Upstream Palliative Care Intervention for Rural and African-American Advanced Cancer Family Caregivers
An Upstream Palliative Care Intervention for Rural Family Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35226
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
FAMILY CAREGIVERS
Inclusion Criteria:
- ≥18 years of age;
- Self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical care and who may or may not live in the same residence as you and who is not paid for their help";
- Either caring for a patient: a) residing in a rural zip code (as classified by the U.S. Census' Rural-Urban Commuting Area [RUCA] system as small rural, large rural, and isolated [hereafter referred to as "rural"]) or b) who is African-American/Black;
- Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below); and
- Caregivers will need NOT need to have an agreeable patient willing to participate in the study (for data collection only).
- English-speaking and able to complete baseline measures.
Exclusion Criteria:
1) Self-reported severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse
PATIENTS
Inclusion Criteria:
- ≥18 years of age;
- Diagnosed within past 60 days of initial screening with an advanced cancer, defined as metastatic stage III/IV solid-tumor cancers of the lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and melanoma; and
- Either: a) resides in a rural zip code or b) is African-American/Black.
Exclusion Criteria:
1) Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
Usual care family caregiver participants will be informed of the UAB Comprehensive Cancer Center Patient and Family Resources webpage.
|
|
Experimental: Project Cornerstone
The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician.
Regular caregiver distress thermometer screening and problem support and self-care coaching.
Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions.
|
Project Cornerstone basic elements are:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of retaining 70 family caregiver-patient dyads
Time Frame: From date of enrollment to 24 weeks
|
Proportion of participants completing study-related assessments from enrollment to 24 weeks
|
From date of enrollment to 24 weeks
|
Feasibility of intervention completion
Time Frame: From date of enrollment to 24 weeks
|
Proportion of participants completing core coaching sessions from enrollment to 24 weeks
|
From date of enrollment to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Caregiver Quality of Life
Time Frame: Baseline, week 8, and week 24
|
The Caregiver Quality of Life Index- Cancer (CQOLC) scale is a 35-item cancer-specific instrument that assesses the carer of a cancer patient's quality of life, that is, some of the physical, social, emotional, and financial aspects of well-being, and functioning.
|
Baseline, week 8, and week 24
|
Family Caregiver Mood (Anxiety/Depressive Symptoms)
Time Frame: Baseline, week 8, and week 24
|
This Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, containing 7 items each for symptoms of depression and anxiety over the past 7 days.
Subscale scores range from 0-21 with scores ≥8 indicating abnormally high symptoms.
|
Baseline, week 8, and week 24
|
Patient Quality of Life
Time Frame: Baseline, week 8, and week 24
|
The Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) is a 46-item scale, composed of physical, emotional, social, and functional well-being and additional concern subscales.
Scores range from 0 to 184, where a higher score represents higher quality of life.
|
Baseline, week 8, and week 24
|
Patient Mood (Anxiety/Depressive Symptoms)
Time Frame: Baseline, week 8, and week 24
|
This Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, containing 7 items each for symptoms of depression and anxiety over the past 7 days.
Subscale scores range from 0-21 with scores ≥8 indicating abnormally high symptoms.
|
Baseline, week 8, and week 24
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James N Dionne-Odom, PhD, RN, University of Alabama at Birmingham
Publications and helpful links
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
Other Study ID Numbers
- K99NR015903 (U.S. NIH Grant/Contract)
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 Family Members
-
Swansea UniversityCardiff University; University Hospitals, Leicester; University Hospital Birmingham... and other collaboratorsCompleted
-
University of Alabama at BirminghamNational Cancer Institute (NCI)RecruitingCancer | Family MembersUnited States
-
University of Alabama at BirminghamUniversity of South AlabamaRecruitingCancer Metastatic | Family MembersUnited States
-
The Hong Kong Polytechnic UniversityNot yet recruitingOld Age | Family Members
-
Lafayette CollegeUniversity of South DakotaRecruitingChild Development | Family Members | GrandparentsUnited States
-
The University of Hong KongCompletedOlder Adults | Family Members | Nursing HomeHong Kong
-
Lady Davis InstituteRecruitingEngagement, Patient | Family Members | Health Care ProvidersCanada
-
Ersta Sköndal University CollegeActive, not recruitingFamily Members | Home Care Services | Support, FamilySweden
-
Children's Hospital of PhiladelphiaCigna FoundationCompletedFamily Members of: Newborns Extremely Premature | Family Members of: New Pediatric Oncology Patients | Family Members of: Critical Congenital Heart Defect Patients | Family Members of: Children Severe Neurological ImpairmentUnited States
-
Washington State UniversityNational Institute of Mental Health (NIMH)Recruiting
Clinical Trials on Project Cornerstone
-
University of Alabama at BirminghamUniversity of South AlabamaRecruitingCancer Metastatic | Family MembersUnited States
-
New York UniversityCompletedDepression | Bipolar Disorder | Stress Disorders, Post-traumaticUnited States
-
Medtronic Spinal and BiologicsCompletedDegenerative Cervical Disc Disease
-
Medtronic Spinal and BiologicsTerminatedDegenerative Cervical Disc Disease
-
Ohio State UniversityMedtronicRecruitingClinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet SpacersCervical FusionUnited States
-
Harvard UniversityCompletedDepression | Stress | AnxietyUnited States
-
Children's National Research InstituteChildren's Hospital ColoradoEnrolling by invitation
-
Harvard UniversityCompletedDepression | Stress | AnxietyUnited States
-
University of Maryland, College ParkAmerican Cancer Society, Inc.; Community Ministry of Prince George's County; Access...CompletedBreast Cancer | Colorectal Cancer | Prostate CancerUnited States
-
Northwestern UniversityNational Institute of Mental Health (NIMH)Active, not recruitingDepressionUnited States