Reducing Chronic Disease Health Disparities in the Deep South

Study Overview
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Brief Summary
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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
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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.

Official Title
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Expanding Our Cancer Prevention and Control Infrastructure to Reduce Cancer and Other Chronic Disease Health Disparities in the Deep South

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: Harvest for Health


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harvest for Health<br>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. | Behavioral: Harvest for Health<br>* Please see previous description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and Retention | We will be tracking the interaction with community master gardeners and study participants using REDCap questionnaires. Information gathered will include: Number of participants recruited Number of visits (total) Number of completed visits (within the window) Number of completed visits (outside of window) | 1 year | 
| Treatment Delivery | The investigators will be administering the EATS survey to all participants designed to measure the intake of fruits and vegetables and has been used widely to track changes in fruit and vegetable intake in specific population groups. This screener termed the By Meal version, asks about usual intakes of fruits and other vegetables by the time of day. Participants list how many servings they eat, an algorithm converts the totals into an average per day; then this average is used to estimate the intake of each participant throughout the study. | 1 year | 
| Treatment Receipt | For this data point, we will administer the Reassurance of Worth instrument (Revised Social Provision Scale [SPS10]): This instrument posits that social support is defined in terms of its function, namely, social provisions. This theory considers the functions of social relationships across specific social roles (e.g., romantic partner, spouse, family members, friends, colleagues, etc.), especially when individuals face critical life-changing events. Social ties provide social support and that specific social ties might meet individuals' different social support needs or might influence individuals to offer social support. The scale is as follows: Strongly Disagree Disagree Agree Strongly Agree 1 2 3 4 SPS-10 can be a useful clinical and research tool to assess perceived social support not only in perinatal and pae-diatric settings, but also in general medical and mental health settings | 1 year | 
| Enactment of Treatment Skills | We will administer the self-efficacy for gardening: This investigator-created screener is designed to gather information on the degree to which participants feel confident working in their own garden. Questions are centered on: 1.) time spent in the garden, 2.) did participants partake in gardening with anyone else, 3.) and whether or not gardening influenced participants to eat more vegetables. | 1 year | 
| Fruit and vegetable intake | We will administer the EATS screener: This assessment tool was designed to measure intake of fruits and vegetables and has been used widely to track changes in fruit and vegetable intake in specific population groups. There are two versions of this screener. This version, termed the By Meal version, asks about usual intakes of fruits and other vegetables by time of day. The other version, termed the All-Day version, asks about usual intakes of all items. Both are machine scan-able. Goal achievement is based on an increase of ≥1 serving/ day of Fruits and vegetables assessed via the EATS score pre-and post-program intervention. | 1 year | 
| SF36 Physical Function Subscale | Goal achievement based on an increase of ≥5 points on the SF36 Physical Function subscale (PFSS) The SF36 PFSS is a 10-item subscale assessing general physical function and is valid and reliable for use in healthy and chronically-ill adults. Internal consistency is excellent: α=0.89 to 0.92. It has published norms, is sensitive to change, and has performed well in our past studies; we have found it free of ceiling effects. | 1 year | 
| Senior Fitness Test Battery | Goal achievement is based on an improvement in > 4 of 6 performance tests Senior Fitness Test Battery tests several physical function domains: lower and upper body strength (30-second chair stand, arm curl), endurance (2-minute step test), flexibility (chair sit and-reach, back scratch), agility/dynamic balance (8-ft Get Up & Go), and gait speed (8-foot walk); the test battery provides an objective measure of physical function, is sensitive to change, not associated with ceiling effects, and has normative scores. Additional test include grip strength, objectively measured via dynamometer (disability and functional limitation predictor). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF12 Health Related Quality of Life Index | SF12 Health Related Quality of Life Index The SF12 Health-Related Quality of Life Index (HRQoL) will provide a global measure of HRQoL, and each of the eight subscales will be explored separate (i.e. Physical functioning, Role-physical, Bodily pain, General health, Vitality, Social functioning, Role-emotional, Mental heat). Internal consistency and reliability for all eight subscales is high, ICC ranging from 0.78 to 0.93. HRQoL weights to create Quality Adjusted Life Years (QALYs) from the SF12 will be done using methods of Brazier & colleagues. | 1-year | 
| Reassurance of Worth: | One of six subscales of the Revised Social Provision Scale, this measure will be used to assess the psychosocial benefits of gardening. Several gardening studies have reported enhanced self-esteem, increased independence, and increased zest for life associated with gardening. Reliability estimates range from 0.60 to 0.70. Social Support and Eating Habits (10 items) and Exercise Surveys (13 items): This has been widely used in diverse samples and has strong psychometric properties (α=.70), surveys will be adapted for gardening using identical anchors | 1-year | 
| Self-Efficacy for Gardening | This is the organizing concept in Social Cognitive Theory and is defined as people's beliefs in their capability to organize and execute courses of action to deal with prospective situations. Self-efficacy beliefs are domain-specific; thus, within the context of this study, self-efficacy is survivors' beliefs in their ability to meet the challenges of maintaining a successful vegetable garden. | 1-year | 
| Physical Activity: Godin Lesiure Time Activity Questionnaire | Goal achievement based on an increase of ≥30 minutes/week of moderate to vigorous activity assessed via Godin Leisure Time Activity Questionnaire. Self-reported physical activity will be provided using the Godin Leisure Time Activity Questionnaire, a validated and sensitive tool that captures physical activities. | 1-year | 
| Weight | Participants will be weighed (to the nearest 0.1 kg) at each assessment (baseline and 1-year) while wearing light clothing without shoes using a professional digital scale regularly calibrated to current standards. | 1year | 
| Height | Participants' height (to the nearest 0.1 cm) will be measured without shoes using a tape measure. Height will be measured only at the baseline. | 1year | 
| Body Mass Index (BMI) | Using weight and height data described above, BMI will be calculated using the equation BMI = weight (kg)/height (m2). | 1year | 
| Waist Circumference | Waist circumference will be measured (to the nearest 0.5cm) at the end of normal expiration on base skin at the belly button using a constant-tension spring-loaded tape device. Measures will be taken in a private room rather than in a larger group setting. A privacy screen or curtain will be used when a larger room must be subdivided for the assessments. | 1year | 
| Blood Pressure | Participant blood pressure (BP) will be measured by trained staff using a calibrated automatic sphygmomanometer. Arm circumference will be measured to determine the proper size arm cuff, to avoid over- or under-estimation of the true BP. Participants will be asked to sit with both feet flat on the floor and to rest without talking for five minutes before measurement. BP will be measured twice according standard NHLBI protocols. The two measurements will be averaged. | 1year | 
| Total Cholesterol | A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required). | 1year | 
| High Density Lipoprotein Cholesterol (HDL-C) | A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required). | 1year | 
| Low Density Lipoprotein Cholesterol (LDL-C) | A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required). | 1year | 
| Glucose and Hemaglobin A1c (HbA1C) | A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required). | 1year |