Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
2016年2月5日 更新者：University of Alabama at Birmingham
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.
研究概览
详细说明
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).
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Mentored Gardening Intervention
Participants in this arm will be provided with either a raised bed garden or 4 earthboxes, gardening supplies, and plants and seeds.
A master gardener from the Cooperative Extension will mentor them over the course of a year to plant three gardens (spring, summer and fall).
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receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
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其他：Wait-List
Participants in this arm will be provided with the same gardening supplies as the other group, but will receive them one year after enrollment in the study.
They also will receive instruction from a master gardener from the Cooperative Extension at this time as well.
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receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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feasibility
大体时间：baseline to 12 months
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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
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baseline to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
physical function
大体时间：baseline to 12 months
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assessed via the SF 36 physical function subscale and the senior fitness battery
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baseline to 12 months
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diet quality
大体时间：baseline to 12 months
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assessed via the Diet History Questionnaire
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baseline to 12 months
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physical activity
大体时间：baseline to 12 months
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assessed via the CHAMPS questionnaire with accelerometry confirmation
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baseline to 12 months
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quality of life
大体时间：baseline to 12 months
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assessed via the SF-36
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baseline to 12 months
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biomarkers of successful aging
大体时间：baseline to 12 months
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assessed via blood (serum) levels of IL-6, VCAM, d-dimer and telomerase and finger/toenail and saliva measures of cortisol
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baseline to 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2014年5月24日
首先提交符合 QC 标准的
2014年5月24日
首次发布 (估计)
2014年5月29日
研究记录更新
最后更新发布 (估计)
2016年2月9日
上次提交的符合 QC 标准的更新
2016年2月5日
最后验证
2015年11月1日
更多信息
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