Clinical trial NCT02150148: Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
Official title: Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: breast cancer
prostate cancer
colorectal cancer
small intestine cancer
thyroid cancer
Hodgkin lymphoma
non-Hodgkin lymphoma
endometrial cancer
kidney cancer
cervical cancer
diet
exercise
physical activity
garden
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-29
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer survivorship has been claimed a national priority, with a call to develop effective interventions that can prevent, delay, or mitigate the adverse effects and comorbidities in this high risk population. Strong evidence exists that a healthful diet and regular physical activity can prevent many chronic diseases and improve physical function. More research however is needed to develop interventions that can produce long-term adherence to healthful lifestyle behaviors. This pilot study is based on the hypothesis that vegetable gardening interventions will be feasible and result in improvements in diet and exercise behaviors as well as improvements in physical functioning and well-being.

Detailed description: The proposed feasibility study relies on the extant infra-structure of the Alabama Cooperative Extension Master Gardener Program. A total of 46 older (≥65 years) cancer survivors recently diagnosed with a loco-regionally staged cancer with a good prognosis (i.e., ≥ 80% 5-year survival) and with 2 or more physical function limitations will be recruited from select rural and urban counties in Alabama and randomized to 1-of-2 study arms: 1) an intervention group that receives a 1-year mentored vegetable gardening intervention that pairs cancer survivors with certified Master Gardeners, or 2) a usual care control group that is observed during the year, but receives the gardening supplies at study completion. Aims of this study are to: 1) explore the feasibility and acceptability of a mentored vegetable gardening intervention by assessing accrual, retention, adherence, fidelity, and possible adverse events, 2) obtain means and precision estimates, and explore between-arm differences on pre-post changes in physical function and secondary endpoints (e.g., quality of life, fruit \& vegetable intake, physical activity, etc.), and 3) to explore participant factors associated with program efficacy (e.g., gender, comorbidity).

Eligibility criteria: Inclusion Criteria:

* diagnosed with a loco-regionally staged cancer associated with an 60% or greater 5-year survival rate (localized and regional staged breast, Hodgkin lymphoma, prostate, ovary, endometrial, colorectal and thyroid cancers; localized cervix, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, small intestine, bladder and soft tissue cancers; and in situ bladder \& breast cancer); and distant Hodgkin Lymphoma, and Testicular cancers.
* resides in select counties in Alabama;
* completed primary curative cancer treatments, i.e., surgery, chemotherapy or radiation therapy;
* at higher risk of functional decline (≥ 1 physical function (PF) limitations as defined by the SF36 PF subscale);
* currently eats less than 5 servings of fruits and vegetables/day;
* exercises less than 150 minutes/ week;
* speaks, reads and writes in English
* 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 with running water;
* willing to be randomized to either study arm and participate in the follow-up.

Exclusion Criteria

* history of lymphedema flares and axillary node dissection of 10 or more lymph nodes on one side of the body;
* 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);
* currently taking pharmacologic doses of warfarin (does not include doses taken to maintain a port); or
* plants a vegetable garden at least annually

Primary outcomes:
measure: feasibility
timeFrame: baseline to 12 months
Secondary outcomes:
measure: physical function
timeFrame: baseline to 12 months
measure: diet quality
timeFrame: baseline to 12 months
measure: physical activity
timeFrame: baseline to 12 months
measure: quality of life
timeFrame: baseline to 12 months
measure: biomarkers of successful aging
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Wendy Demark-Wahnefried, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blair CK, Madan-Swain A, Locher JL, Desmond RA, de Los Santos J, Affuso O, Glover T, Smith K, Carley J, Lipsitz M, Sharma A, Krontiras H, Cantor A, Demark-Wahnefried W. Harvest for health gardening intervention feasibility study in cancer survivors. Acta Oncol. 2013 Aug;52(6):1110-8. doi: 10.3109/0284186X.2013.770165. Epub 2013 Feb 26.
citation: Cases MG, Blair CK, Hendricks PS, Smith K, Snyder S, Demark-Wahnefried W. Sustainability capacity of a vegetable gardening intervention for cancer survivors. BMC Public Health. 2022 Jun 22;22(1):1238. doi: 10.1186/s12889-022-13644-5.
citation: Demark-Wahnefried W, Cases MG, Cantor AB, Fruge AD, Smith KP, Locher J, Cohen HJ, Tsuruta Y, Daniel M, Kala R, De Los Santos JF. Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity. J Acad Nutr Diet. 2018 Apr;118(4):689-704. doi: 10.1016/j.jand.2017.11.001. Epub 2018 Jan 2.