Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

Cancer Clinical Trial

Official title:

Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150148
• Other study ID #: CA182508
• Secondary ID: R21CA182508-01
• Status: Completed
• Phase: N/A
• First received: May 24, 2014
• Last updated: February 5, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility	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	baseline to 12 months	Yes
Secondary	physical function	assessed via the SF 36 physical function subscale and the senior fitness battery	baseline to 12 months	No
Secondary	diet quality	assessed via the Diet History Questionnaire	baseline to 12 months	No
Secondary	physical activity	assessed via the CHAMPS questionnaire with accelerometry confirmation	baseline to 12 months	No
Secondary	quality of life	assessed via the SF-36	baseline to 12 months	No
Secondary	biomarkers of successful aging	assessed via blood (serum) levels of IL-6, VCAM, d-dimer and telomerase and finger/toenail and saliva measures of cortisol	baseline to 12 months	No