Southwest Harvest for Health Vegetable Gardening Intervention

Study Overview
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Brief Summary
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Harvest for Health is a home-based vegetable gardening intervention that pairs cancer survivors with certified master gardeners (MGs) from the Cooperative Extension System, the education and outreach arm of land-grant universities nationwide.

Detailed Description
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Few lifestyle behavior change interventions have been successfully translated into practice. Addressing this research-to-practice gap is a significant research and public health priority. Harvest for Health is a home-based vegetable gardening intervention that pairs cancer survivors with certified Master Gardeners from the Cooperative Extension System. The parent study was started at the University of Alabama at Birmingham and is currently being conducted throughout the entire state of Alabama. Preliminary findings suggest that this intervention increases vegetable consumption and physical activity, and improves physical functioning and health-related quality of life. We propose a feasibility study to adapt this promising program to the multi-cultural population of cancer survivors and for the local context (physical, social, and cultural environment) of New Mexico. We will then implement the adapted program, Southwest Harvest for Health and evaluate feasibility, acceptability, and fidelity. The adaptation phase is a critical first step towards widespread dissemination, implementation, and scale-up of an evidence-based intervention.

Official Title
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Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico

Conditions
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Cancer Survivor

Intervention / Treatment
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* Behavioral: home-based, mentored vegetable gardening program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 years or older Residing in Bernalillo or Sandoval County, New Mexico Diagnosed with an invasive cancer (any type) Completed primary treatment (surgery, radiation, chemotherapy)(note: endocrine therapy is allowed) Able to read, speak, and understand English (The future larger trial will include Spanish-Speaking participants) Not told by a physician to limit physical activity and no pre-existing medical condition(s) that would preclude home gardening, e.g., severe orthopedic conditions, hip or knee replacement surgery within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of myocardial infarction, congestive heart failure, or pulmonary conditions that required oxygen or hospitalization within 6 months. Currently not adhering to the recommended number of fruit and vegetable servings per day (consuming fewer than 5 servings of vegetables and fruits/day and not meeting the recommended guidelines for moderate-to-vigorous physical activity (< 150 minutes/week) Reside in a location that can accommodate a 4' x 8' raised garden bed or 4 (29 x 14) garden containers, or adequate (at least 4 hours) of sunlight per day and have access to running water No existing or recent (within the past year) experience with vegetable gardening Able to participate in the 10-month intervention (all three seasonal gardens; from mid-February through early November 2020)

Ages Eligible for Study
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Minimum Age: 50 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All participants will receive the 10-month mentored, vegetable gardening intervention | Behavioral: home-based, mentored vegetable gardening program<br>* The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adaptation -- systematic documentation using the Framework for Reporting Adaptations and Modifications Enhanced (FRAME) tool (Stirman et al., Implementation Science, 2019) | Adaptation is the degree to which an intervention is modified in the process of its adoption and implementation. Adaptation requires a careful balance between achieving fit, i.e., modifying a program to meet the needs of a new target population or local context, and maintaining fidelity, i.e., minimizing changes that could negatively affect the program's effectiveness. Adaptation of the Harvest for Health intervention for the local context (physical, social, and cultural environment) of New Mexico | through study completion, an average of 9 months | 
| Feasibility of the intervention | Ability to recruit 25 cancer survivors in 3 months, achieve 80% retention rates, 80% adherence to the intervention, and high acceptability of the program for both cancer survivors (participants) and Cooperative Extension Master Gardeners. | through study completion, an average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-post change in vegetable and fruit intake | The number of daily servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals increase by more than one serving of vegetables/fruits per day. | baseline to 9-months | 
| Pre-post change in objectively measured physical activity | Physical activity will be objectively measured using the activPAL research grade monitor. | baseline to 9-months | 
| Pre-post change in sleep quality | Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance. | baseline to 9-months | 
| Pre-post change in physical function | Self-reported physical function will be assessed using the 8-item physical function scale. | baseline to 9-months | 
| Pre-post change in physical performance | Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery. | baseline to 9-months |