Clinical trial NCT04297826: Reducing Chronic Disease Health Disparities in the Deep South
Official title: Expanding Our Cancer Prevention and Control Infrastructure to Reduce Cancer and Other Chronic Disease Health Disparities in the Deep South
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
name: Mississippi State University
name: University of South Carolina
First posted: 2020-03-06
Enrollment: 137
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 program focuses on 15 counties where a Community Health Advisor training program is in place (Bullock, Calhoun, Dallas Madison, Marengo, Monroe, Sumter, Talladega, Walker Counties in Alabama and Boliver, Granada, Humphrey, Panola, Sunflower, and Yazoo Counties in Mississippi). Participants are paired with Cooperative Extension certified Master Gardeners to plant a vegetable garden at their place of residence (the intervention). Baseline, midpoint, and 1 year follow up will occur. Previous pilot work provides an established relationship with the Cooperative Extension as well as training mechanisms for the Master Gardeners.

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 individuals living with chronic diseases in 15 counties in Alabama and Mississippi. The purpose of this larger study is to determine the efficacy of a gardening intervention that would pair older cancer survivors and individuals living with chronic disease (heart disease and diabetes) (≥ 65 years of age) with master gardeners. Vegetable gardens will be established at participants' homes, and a yearlong intervention involving bimonthly contact between participants and MGs to plan and plant gardens, check plant status, harvest, and rotate plantings will be conducted. It is hypothesized that this intervention will significantly improve fruit and vegetable consumption, physical activity, quality of life and physical functioning.

Outcomes: Outcomes will be measured by the number of participants recruited, improvements in physical functioning, physical performance (senior fitness battery and grip strength), physical activity, health-related quality of life, reassurance of worth, and self-efficacy of gardening. Additional outcomes are blood pressure, BMI, waist circumference, lipid, glucose, and HbA1c.

Background: There are roughly 15 million cancer survivors in the US, comprising 4% of the populace. The number of cancer survivors is skyrocketing due to a confluence of the following factors: 1) Americans are aging; 2) cancer is an age-related disease (\>60% of cancer survivors are age 65+), and 3) improvements in early detection and treatment have resulted in many common cancers having 5-year cure rates that surpass 90%. Rising numbers of cancer survivors represent good news, but over $130 billion annually is needed to address their long-term health and psychosocial needs. Compared to others, cancer survivors are at higher risk for other cancers, cardiovascular disease, osteoporosis, and diabetes. The accelerated functional decline also is a major problem for cancer survivors, especially those who are older. Baker et al. found that compared to age-matched controls, cancer cases (n=45,494) had significantly lower physical and social functioning, vitality, mental health, and health-related quality of life (HRQoL) (p\<0.001). The results of others are similar and suggest that cancer survivors face functional decline that threatens their ability to live independently, posing a burden to themselves, their families and the health care system. Thus, cancer survivorship is claimed as a national priority, and there is a call for interventions that target markedly vulnerable subsets.

Prior interventions to improve physical activity (PA) and diet quality (DQ) has proven effective in improving functional status and other health outcomes in cancer survivors. The 2 largest randomized controlled trials (RCTs) to date aimed at physical function, RENEW (Reach-out to ENhancE Wellness, n=641) and Project LEAD (Leading the way in Exercise and Diet, n=182), were led by Demark-Wahnefried (PI) and tested home-based interventions. Both RCTs resulted in significant improvements in DQ, PA and physical function, with few adverse events and low rates of attrition, but there was little capacity for dissemination once funding ended. Thus, the investigators have sought to develop interventions that build on existing programs and that have a high likelihood of translation into the community. The proposed intervention relies on (a) the extant infrastructure of the Alabama Cooperative Extension, (b) our collaborative pilot studies with Master Gardeners (MGs), (c) our data that show that gardening consists of low-to-moderate PA that combines aerobic and strength training activities associated with improved health, and (d) new observational data published in 2012 that show that gardeners have significantly better gait speed, balance, and significantly fewer chronic conditions, functional limitations and falls.

MG Programs exist in land grant universities in all 50 United States. Certified MGs complete \> 100 hrs. of instruction and community service (CS) and 25 hrs./year of CS to maintain active status. In surveying 184 MGs in AL, it was found that 71% were "extremely interested" in mentoring a cancer survivor on vegetable gardening for their CS, and an extra 26% stated that "they were interested and wanted to learn more." Thus, the project is of great interest and builds on an extant infrastructure for sustainability. Ultimately, this intervention could be disseminated to states with 3 growing seasons and adapted to colder weather in those with 2 growing seasons. The intervention also could be adapted for persons with other types of chronic diseases in which physical functioning and lifestyle behaviors are key. Finally, this project is significant because the intervention has great potential for sustainability since gardening: (a) involves many activities which prevent satiation common with other forms of exercise; (b) provides a sense of achievement and zest for life that come from nurturing and observing new life and growth, and (c) imparts natural prompts since plants require regular care (watering) and attention (harvesting) and serve as continual and dynamic behavioral cues.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and Retention
timeFrame: 1 year
measure: Treatment Delivery
timeFrame: 1 year
measure: Treatment Receipt
timeFrame: 1 year
measure: Enactment of Treatment Skills
timeFrame: 1 year
measure: Fruit and vegetable intake
timeFrame: 1 year
measure: SF36 Physical Function Subscale
timeFrame: 1 year
measure: Senior Fitness Test Battery
timeFrame: 1 year
Secondary outcomes:
measure: SF12 Health Related Quality of Life Index
timeFrame: 1-year
measure: Reassurance of Worth:
timeFrame: 1-year
measure: Self-Efficacy for Gardening
timeFrame: 1-year
measure: Physical Activity: Godin Lesiure Time Activity Questionnaire
timeFrame: 1-year
measure: Weight
timeFrame: 1year
measure: Height
timeFrame: 1year
measure: Body Mass Index (BMI)
timeFrame: 1year
measure: Waist Circumference
timeFrame: 1year
measure: Blood Pressure
timeFrame: 1year
measure: Total Cholesterol
timeFrame: 1year
measure: High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: 1year
measure: Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 1year
measure: Glucose and Hemaglobin A1c (HbA1C)
timeFrame: 1year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Various Counties (Bullock, Calhoun, Dallas, Madison, Marengo, Monroe, Sumter, Talladega, Walker)
state: Alabama
city: Jackson
country: United States
facility: Various Counties (Bolivar, Grenada, Humphreys, Panola, Sunflower, Yazoo)
state: Mississippi
Study officials:
affiliation: University of Alabama at Birmingham
name: Monica Baskin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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