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CancerNCT02150148

Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

A study testing Experimental: Mentored Gardening Intervention in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cancer
What is being tested?
Experimental: Mentored Gardening Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
Apr 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

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.

Read the 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).

Conditions
Cancer
Being tested
Experimental: Mentored Gardening Intervention
Keywords
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
Medical subject headings
Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Thyroid Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Mentored Gardening InterventionBehavioural

    receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening

Study groups in NCT02150148
Study groupRoleWhat they receive
Mentored Gardening InterventionExperimentalParticipants 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).
Receives: Behavioral: Experimental: Mentored Gardening Intervention
Wait-ListOtherParticipants 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.
Receives: Behavioral: Experimental: Mentored Gardening Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline to 12 months

Secondary outcomes (5)

  1. physical function

    assessed via the SF 36 physical function subscale and the senior fitness battery

    Measured: baseline to 12 months

  2. diet quality

    assessed via the Diet History Questionnaire

    Measured: baseline to 12 months

  3. physical activity

    assessed via the CHAMPS questionnaire with accelerometry confirmation

    Measured: baseline to 12 months

  4. quality of life

    assessed via the SF-36

    Measured: baseline to 12 months

  5. 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

    Measured: baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02150148
Sponsor's protocol ID
CA182508
Other IDs
R21CA182508-01
Status last verified
Nov 2015
First submitted
24 May 2014
Last updated
9 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23438359

  • 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.

    PubMed 35733142

  • 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.

    PubMed 29305129

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Mentored Gardening Intervention in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02150148, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.

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