Status:
COMPLETED
Reducing Chronic Disease Health Disparities in the Deep South
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Mississippi Medical Center
Mississippi State University
Conditions:
Chronic Disease
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The study is a gardening intervention among 150 older cancer survivors and individuals living with chronic disease (cardiovascular disease and diabetes) in the states of Alabama and Mississippi. This ...
Detailed Description
Based on the investigator's previously successful gardening interventions that paired cancer survivors with Cooperative Extension Master Gardeners (MG) since 2011, now proposed; a sample of 150 older ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men and women diagnosed with a cancer of favorable prognosis (localized and regional staged female breast, and prostate cancers; localized colon \& rectum, uterine cervix \& corpus, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, and esophagus cancers; and in situ bladder cancer); and have no medical conditions that would preclude gardening or the consumption of a diet high in fruits and vegetables (e.g., pharmacologic doses of warfarin) -In addition, men and women living who are medically stable, but managing chronic disease (cardiovascular disease and/ or diabetes) are eligible.
- We will include individuals who:
- (1) are diagnosed with a loco-regionally staged cancer associated with an 80% or greater 5-year survival rate (localized and regional staged female breast, and prostate cancers; localized colon \& rectum, uterine cervix \& corpus, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, and esophagus cancers; and in situ bladder cancer)
- (2) diagnosed with diabetes or cardiovascular disease
- (3) reside in the 15 counties;
- (4) completed primary curative cancer treatments, i.e., surgery, chemotherapy or radiation therapy;
- (5) are at least 65 years of age;
- (6) are at higher risk of functional decline (≥ 2 physical function (PF) limitations as defined by the SF12PF subscale);
- (7) currently eat less than 5 servings of fruits and vegetables (F/V)/ day;
- (8) exercise less than 150 minutes/ week;
- (9) speak and write in English (some of our scales are not validated in other populations/languages); and
- (10) are willing to participate in the follow-up assessments;
- (11) competent to provide informed consent;
- (12) Access to a phone and/ or email and internet
- We will exclude individuals who:
- (1) are not competent due to mental health or other very serious comorbid conditions (e.g., severe orthopedic conditions or scheduled for a hip or knee replacement with 6 months, paralysis, unstable angina or who have experienced a myocardial infarction, congestive heart failure or pulmonary conditions that require hospitalization or oxygen within 6 months, stroke, degenerative neurological conditions, unstable angina (UA), percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), severe valve disease or New York Heart Association (NYHA\_ class III-IV heart failure);
- (2) have any medical condition substantially limiting moderate physical activity;
- (3) currently taking pharmacologic doses of warfarin (does not include doses taken to maintain a port);
- (4) do not reside in a location that can accommodate 4 or more Earthboxes or 1-raised bed (4'x 8'), and that get at least 4 hours of sun a day;
- (5) do not have running water;
- (6) have recent experience with vegetable gardening, e.g. planted a vegetable garden within the past year;
- (7) have a history of lymphedema flares, axillary node dissection of 10 or more lymph nodes per side;
- (8) life expectancy of less than 1 year ;
- (9) Untreated cardiac conditions including complex congenital heart disease, or untreated complex arrhythmias; or
- (10) Current substance abuse
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04297826
Start Date
March 1 2021
End Date
November 30 2022
Last Update
December 15 2022
Active Locations (2)
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1
Various Counties (Bullock, Calhoun, Dallas, Madison, Marengo, Monroe, Sumter, Talladega, Walker)
Birmingham, Alabama, United States, 35294-4410
2
Various Counties (Bolivar, Grenada, Humphreys, Panola, Sunflower, Yazoo)
Jackson, Mississippi, United States, 39216