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Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02150148
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : February 9, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Experimental: Mentored Gardening Intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: 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).
Behavioral: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening

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.
Behavioral: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening




Primary Outcome Measures :
  1. feasibility [ 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


Secondary Outcome Measures :
  1. physical function [ Time Frame: baseline to 12 months ]
    assessed via the SF 36 physical function subscale and the senior fitness battery

  2. diet quality [ Time Frame: baseline to 12 months ]
    assessed via the Diet History Questionnaire

  3. physical activity [ Time Frame: baseline to 12 months ]
    assessed via the CHAMPS questionnaire with accelerometry confirmation

  4. quality of life [ Time Frame: baseline to 12 months ]
    assessed via the SF-36

  5. biomarkers of successful aging [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150148


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02150148    
Other Study ID Numbers: CA182508
R21CA182508-01 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: November 2015
Keywords provided by University of Alabama at Birmingham:
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