Harvest for Health in Older Cancer Survivors

NCT02985411 | Completed DMC

• 2 other identifiers: site gardenR01CA201362-01A1
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer Survivor

Outcome Measures

Primary Outcomes (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.

  1 year after baseline

Secondary Outcomes (10)

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

  1 years after baseline

• Mean physical performance (senior fitness battery) score

  1 year after baseline

• Mean vegetable and Fruit Consumption in each group

  1 year after baseline

• Mean plasma alpha carotene value in each group

  1 year after baseline

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

  1 year after baseline

Study Arms (2)

Immediate Gardening Intervention

ACTIVE COMPARATOR

Wait-listed, will receive the gardening intervention after a 1-year period

Behavioral: Immediate Gardening Intervention

Delayed Gardening Intervention

ACTIVE COMPARATOR

Individuals in this group will serve as their own control

Other: Delayed Gardening Intervention

Interventions

Immediate Gardening Intervention BEHAVIORAL

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,

Immediate Gardening Intervention

Delayed Gardening Intervention OTHER

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

Delayed Gardening Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator
• Auburn University: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (8)

• 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.

  PMID: 27565830 BACKGROUND

• 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.

  PMID: 23438359 BACKGROUND

• 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.

  PMID: 29305129 BACKGROUND

• 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.

  PMID: 29932460 BACKGROUND

• 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.

  PMID: 38900426 DERIVED

• 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.

  PMID: 35533876 DERIVED

• 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.

  PMID: 35017097 DERIVED

• 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.

  PMID: 34342814 DERIVED

Study Officials

• Wendy Demark-Wahnefried, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: October 1, 2016
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)