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Harvest for Health in Older Cancer Survivors

NCT ID: NCT02985411

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2022-05-15

Brief Summary

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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.

Detailed Description

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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

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Cancer Survivor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Immediate Gardening Intervention

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

Group Type ACTIVE_COMPARATOR

Immediate Gardening Intervention

Intervention Type 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,

Delayed Gardening Intervention

Individuals in this group will serve as their own control

Group Type ACTIVE_COMPARATOR

Delayed Gardening Intervention

Intervention Type OTHER

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

Interventions

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Immediate Gardening Intervention

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,

Intervention Type BEHAVIORAL

Delayed Gardening Intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Auburn University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Wendy Demark-Wahnefried, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Demark-Wahnefried, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27565830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23438359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29305129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29932460 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38900426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35533876 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35017097 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34342814 (View on PubMed)

Other Identifiers

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R01CA201362-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

site garden

Identifier Type: -

Identifier Source: org_study_id