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Cancer SurvivorNCT02985411

Harvest for Health in Older Cancer Survivors

A study testing Immediate Gardening Intervention and Delayed Gardening Intervention in people with Cancer Survivor, 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

Gardening interventions yield a multitude of measurable benefits that are evaluable within the context of a clinical trial. Harvest for Health forges new inroads in the delivery of holistic interventions to high risk populations, in this case, older cancer survivors. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Cancer Survivor
What is being tested?
Immediate Gardening Intervention and Delayed Gardening Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
381 participants
Where
1 siteUnited States
Study dates
1 Oct 2016to 15 May 2022
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Residence in the following counties in Alabama: Autauga, Baldwin, Blount, Calhoun, Cherokee, Chilton, Coffee, Cullman, Dale, Dekalb, Elmore, Etowah. Houston, Jackson, Jefferson, Lauderdale, Lee, Limestone, Madison, Marshall, Mobile, Morgan, Montgomery, Pike, Randolph, Shelby, St. Clair, Tallapoosa, Tuscaloosa, Walker
  • Diagnosed with one of the following cancers and completed primary treatment: localized larynx, gastric cardia, or cervix; localized or regionally-staged bladder, colorectum, fallopian tube, breast (female only), kidney and renal, melanoma, oral cavity, ovary, pharynx, prostate, soft tissue sarcoma, thyroid or uterus; or all stages: Hodgkin or Non-Hodgkin Lymphoma, Leukemia (CML CLL ALL) or testis.
  • has at least one physical function limitation as measured by the SF-36 physical function subscale.

Who cannot join

  • Currently tends an in-ground vegetable garden year round.
  • Currently eats at least 2.5 cups of fruits and vegetable/day
  • Currently obtains 150 or more of moderate-to-vigorous exercise per week
  • Has a medical condition that precludes safe pursuit of gardening, i.e., severe orthopedic conditions, pending hip/knee replacement (within 6 mo.), paralysis, dementia, blindness, untreated stage 3 hypertension, or myocardial infarction, congestive heart failure, or conditions that required oxygen or hospitalization within 6 mo.
  • unsuitable residence for gardening, i.e., no running water, inadequate sunshine.
  • not able to speak or read English

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

Gardening interventions yield a multitude of measurable benefits that are evaluable within the context of a clinical trial. Harvest for Health forges new inroads in the delivery of holistic interventions to high risk populations, in this case, older cancer survivors. Since the intervention banks on an existing organization's infrastructure, it can easily be disseminated nationwide. The next step is to prove efficacy - an essential step in contributing to the science in this area, and one which is crucial for future dissemination.

Read the detailed description

There are roughly 15 million cancer survivors in the US, comprising 4% of the populace. The number of cancer survivors is skyrocketing due to a confluence of the following factors: 1) Americans are aging; 2) cancer is an age-related disease (>60% of cancer survivors are age 65+); and 3) improvements in early detection and treatment have resulted in many common cancers having 5-year cure rates that surpass 90%. Rising numbers of cancer survivors is good news, but over $130 billion annually is needed to address subjects long-term health and psychosocial needs.113 Compared to others, cancer survivors are at higher risk for other cancers, CVD, osteoporosis, and diabetes. Accelerated functional decline also is a major problem for cancer survivors, especially those who are older. Baker et al. found that compared to age-matched controls, cancer cases (n=45,494) had significantly lower physical and social functioning, vitality, mental health, and HRQoL (p<0.001). Results of others are similar and suggest that cancer survivors face functional decline that threatens subject ability to live independently, posing a burden to themselves, subject families and the health care system. Programs exist in land grant universities in all 50 United States. Certified MGs complete > 100 hrs. of training and community service (CS) and 25 hrs./year of CS to maintain active status. In surveying 184 MGs in AL, the investigators found that 71% were "extremely interested" in mentoring a cancer survivor on vegetable gardening for subject CS, and an extra 26% stated that "they were interested and wanted to learn more." Thus, the project is of great interest and builds on an extant infrastructure for sustainability. Ultimately, this intervention could be disseminated to states with 3 growing seasons and adapted to colder weather in those with 2 growing seasons (36 states where 10.8 million older cancer survivors reside). The intervention also could be adapted for persons with other chronic diseases in which physical functioning and lifestyle behaviors are key. Finally, this project is significant because the intervention has great potential for sustainability since gardening: (a) involves many activities which prevent burn-out common with other forms of exercise, and allows participants to pursue PA outdoors which is related to greater enjoyment; (b) provides a sense of achievement and zest for life that come from nurturing and observing new life and growth; and (c) imparts natural prompts since plants require regular care (watering) and attention (harvesting) and serve as continual and dynamic behavioral cues.

Conditions
Cancer Survivor
Being tested
Immediate Gardening Intervention, Delayed Gardening Intervention

What participants receive

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

  • Immediate Gardening InterventionBehavioural

    Provided with supplies to plan/plant 3 vegetable gardens over the course of a year. Survivors will be paired with a master gardener from their local Cooperative Extension to help guide them and provide mentorship in vegetable gardening,

  • Delayed Gardening InterventionOther

    Subjects will be monitored for 1-year and will then receive the same vegetable gardening intervention as described under the Immediate Gardening Intervention

Study groups in NCT02985411
Study groupRoleWhat they receive
Immediate Gardening InterventionActive comparatorWait-listed, will receive the gardening intervention after a 1-year period
Receives: Behavioral: Immediate Gardening Intervention
Delayed Gardening InterventionActive comparatorIndividuals in this group will serve as their own control
Receives: Other: Delayed Gardening Intervention

What is being measured

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

  1. Percent of subjects in each group at year 1 who meet ALL 3 of 3 of the following goals: Physical performance tests, plasma α-carotene, and accelerometry-measured physical exam

    Percent of subjects in each group at year 1 who meet ALL 3 of 3 of the following goals: Physical performance tests, plasma α-carotene, and accelerometry-measured PA

    • >5-point increase on the Short Form 36 Physical Function subscale [SF36 PFSS] AND improvement on the Senior Fitness Battery
    • Increase in intake of ½ c of vegetables and fruits/day AND increase is plasma alpha-carotene.
    • Increase of >30 minutes per week of moderate to vigorous physical activity AND confirmatory increase in physical activity as assessed by accelerometry.

    Measured: 1 year after baseline

Secondary outcomes (10)

  1. Mean Physical Functioning (SF36 physical function subscale) score in each group

    The 10-item scale measures perceived limitations to various physical tasks in which the participant response "limited a lot," "limited a little" or "not limited at all" (A 3-point scale is used and the score is transformed to a 0-100 point scale in which a score of 50 reflects an average score (with a 100 reflecting no limitations and 0 means severe limitations in multiple domains

    Measured: 1 years after baseline

  2. Mean physical performance (senior fitness battery) score

    The Senior Fitness Test Battery tests several physical function domains: i.e., lower and upper body strength (using the 30-second chair stand and arm curl), endurance (using the 2-minute step test), flexibility (using the chair sit-and-reach and back scratch), and agility/dynamic balance (using the 8-ft Get Up \& Go). Each test is backed by age and gender appropriate population-based norms; cutpoints denoting high risk for low function are as follows:

    • 30-second chair stand: <8 unassisted stands
    • Arm curl: <11 curls
    • 2-minute step test: <65 steps
    • Chair sit-and-reach: -4 cm in men and -2 cm in women
    • Back scratch: -4 cm in men and -2 cm in women
    • 8 foot Get up and Go: > 9 seconds

    Measured: 1 year after baseline

  3. Mean vegetable and Fruit Consumption in each group

    The number of daily ½ cup servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals meet the goal (2.5 cups per day) or not.

    Measured: 1 year after baseline

  4. Mean plasma alpha carotene value in each group

    Plasma α-carotene will be quantified via high-performance liquid chromatography methods using a Hitachi 911clinical analyzer with standard chemistries by Roche (Indianapolis, IN). The range of α-Carotene varies from 0.1 to 0.90 μmol/ with a mean score of 0.5. This test is conducted for research purposes only. Thus, while a range between 0.50 and 0.90 is desirable, there are no clinically agreed guidelines to provide patients with information on lower levels.

    Measured: 1 year after baseline

  5. Mean rate of physical activity (self report via the CHAMPS and accelerometry

    Physical activity will be measured via self-report, using the Community Healthy Activities Models Program for Seniors (CHAMPS), a validated and sensitive tool that captures physical activities specific to older adults. This instrument will be used to assess minutes of moderate to vigorous activity per week. Objective levels of physical activity, will be captured via accelerometry. All participants will be asked to wear an activity monitor on their waist for 7 days at baseline, 1- and 2- year follow-up. Readings obtained from accelerometry also will be used to assess the minutes of moderate to vigorous physical activity.

    Measured: 1 year after baseline

  6. Mean percent improvement on the Senior Fitness Battery test

    Change from baseline to 1-year follow-up in each measure of physical performance will be compared between those in the immediate vs. delayed intervention groups at 1-year.

    Measured: 1 year post baseline

  7. Mean percentage BMI score at 2 years post baseline

    An improved diet and improved physical activity is associated with a weight status within the normal range, we will assess changes in weight status over the study period by measuring height (at baseline), and weight (using a platform scale) at all timepoints. Weights and heights will be converted to MI (KG/M2). The percentage of each study arm categorized as normal weight (BMI 18.5 - 24.9) at each time point.

    Measured: baseline to 2 years

  8. Mean Quality of Life (SF36) score at 2 years

    The SF-36 offers scores for mental health and physical health. These scores are each transformed to a 0-100 point scale in which a score of 50 reflects an average score (with a 100 reflecting optimal status and 0 meaning severly compromised (minimal) status

    Measured: 2 years after baseline

  9. Mean telomerase score in each group

    PENDING RECEIPT OF ANCILLARY FUNDING: Telomerase activity will be measured in blood sample buffy coats using the Telomerase PCR ELISA assay (Boehringer Mannheim). While many individuals will express non-detectable levels, the percentage of individuals who have optimal levels of 0.20-1.5 will be compared in each arm

    Measured: 1 year post baseline

  10. Mean IL-6 and TNF alpha score in each arm

    IL-6 will be assessed IN PLASMA via electrochemiluminescence (Meso-scale Discovery; Gaithersburg, MD). AN ANTICIPATED RANGE OF 0.015 to 11.5 pg/ml IS ANTICIPATED, WITH LOWER LEVELS INDICATING LESS INFLAMMATION AND LOWER RISK FOR CHRONIC DISEASE (VALUES <1.47)

    Measured: 1 year post baseline

Timeline

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

  1. First posted7 Dec 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion15 May 2022
  4. Study completion15 May 2022

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
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985411
Sponsor's protocol ID
site garden
Other IDs
R01CA201362-01A1
Status last verified
Jun 2022
First submitted
3 Dec 2016
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Will not share data until study is complete and all data deidentified

Publications

  • Cases MG, Fruge AD, De Los Santos JF, Locher JL, Cantor AB, Smith KP, Glover TA, Cohen HJ, Daniel M, Morrow CD, Moellering DR, Demark-Wahnefried W. Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors. Contemp Clin Trials. 2016 Sep;50:201-12. doi: 10.1016/j.cct.2016.08.014. Epub 2016 Aug 23.

    PubMed 27565830

  • 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

  • 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

  • Bail JR, Fruge AD, Cases MG, De Los Santos JF, Locher JL, Smith KP, Cantor AB, Cohen HJ, Demark-Wahnefried W. A home-based mentored vegetable gardening intervention demonstrates feasibility and improvements in physical activity and performance among breast cancer survivors. Cancer. 2018 Aug;124(16):3427-3435. doi: 10.1002/cncr.31559. Epub 2018 Jun 22.

    PubMed 29932460

  • Demark-Wahnefried W, Oster RA, Smith KP, Kaur H, Fruge AD, Cole WW, Locher JL, Rocque GB, Pisu M, Bail JR, Cohen HJ, Moellering DR, Blair CK. Vegetable Gardening and Health Outcomes in Older Cancer Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417122. doi: 10.1001/jamanetworkopen.2024.17122.

    PubMed 38900426

  • Bail JR, Blair CK, Smith KP, Oster RA, Kaur H, Locher JL, Fruge AD, Rocque G, Pisu M, Cohen HJ, Demark-Wahnefried W. Harvest for Health, a Randomized Controlled Trial Testing a Home-Based, Vegetable Gardening Intervention Among Older Cancer Survivors Across Alabama: An Analysis of Accrual and Modifications Made in Intervention Delivery and Assessment During COVID-19. J Acad Nutr Diet. 2022 Sep;122(9):1629-1643. doi: 10.1016/j.jand.2022.05.005. Epub 2022 May 6.

    PubMed 35533876

  • Kaur H, Fernandez JR, Locher JL, Demark-Wahnefried W. Rural and Urban Differences in Vegetable and Fruit Consumption Among Older Cancer Survivors in the Deep South: An Exploratory Cross-Sectional Study. J Acad Nutr Diet. 2022 Sep;122(9):1717-1724.e4. doi: 10.1016/j.jand.2022.01.003. Epub 2022 Jan 10.

    PubMed 35017097

  • Warnock AC, Kaur H, Buckman JR, Hoenemeyer T, Demark-Wahnefried W. A comparison of two mail-based strategies to recruit older cancer survivors into a randomized controlled trial of a lifestyle intervention. J Cancer Surviv. 2022 Oct;16(5):998-1003. doi: 10.1007/s11764-021-01091-x. Epub 2021 Aug 3.

    PubMed 34342814

Questions about this trial

What is this clinical trial studying?

A study testing Immediate Gardening Intervention and Delayed Gardening Intervention in people with Cancer Survivor, 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 3 inclusion and 6 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 15 Dec 2022. 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?

Percent of subjects in each group at year 1 who meet ALL 3 of 3 of the following goals: Physical performance tests, plasma α-carotene, and accelerometry-measured physical exam (time frame: 1 year after baseline). 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 NCT02985411, which also lists 8 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 15 Dec 2022.

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