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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

Tracking Information
First Submitted Date  ICMJE May 24, 2014
First Posted Date  ICMJE May 29, 2014
Last Update Posted Date February 9, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2014)
  • physical function [ Time Frame: baseline to 12 months ]
    assessed via the SF 36 physical function subscale and the senior fitness battery
  • diet quality [ Time Frame: baseline to 12 months ]
    assessed via the Diet History Questionnaire
  • physical activity [ Time Frame: baseline to 12 months ]
    assessed via the CHAMPS questionnaire with accelerometry confirmation
  • quality of life [ Time Frame: baseline to 12 months ]
    assessed via the SF-36
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
Official Title  ICMJE Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Experimental: Mentored Gardening Intervention
  • 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.
    Intervention: Behavioral: Experimental: Mentored Gardening Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2014)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02150148
Other Study ID Numbers  ICMJE CA182508
R21CA182508-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP