University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT02150148
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.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
Time frame: baseline to 12 months
attainment of accrual target of 46 eligible enrolled participants, retention of at least 80% of participants over the 12-month study period and the absence of any serious events attributable to the intervention
Time frame: baseline to 12 months
assessed via the SF 36 physical function subscale and the senior fitness battery
Time frame: baseline to 12 months
assessed via the Diet History Questionnaire
Time frame: baseline to 12 months
assessed via the CHAMPS questionnaire with accelerometry confirmation
Time frame: baseline to 12 months
assessed via the SF-36
Time frame: baseline to 12 months
assessed via blood (serum) levels of IL-6, VCAM, d-dimer and telomerase and finger/toenail and saliva measures of cortisol
University of Alabama at Birmingham
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06171945
Behavior, Body Weight
Chapel Hill, North Carolina, United States
View Trial DetailsNCT05131815
Astrocytoma, Behavior
Los Angeles, California, United States
View Trial DetailsNCT00538850
Adenocarcinoma, Adenoma
Chandler, Arizona, United States
View Trial DetailsNCT04485013
Adenocarcinoma, Adenocarcinoma of Lung
Tucson, Arizona, United States
View Trial Details