- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985411
Harvest for Health in Older Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Immediate Gardening Intervention
Wait-listed, will receive the gardening intervention after a 1-year period
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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,
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Active Comparator: Delayed Gardening Intervention
Individuals in this group will serve as their own control
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Subjects will be monitored for 1-year and will then receive the same vegetable gardening intervention as described under the Immediate Gardening Intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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1 year after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Physical Functioning (SF36 physical function subscale) score in each group
Time Frame: 1 years after baseline
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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
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1 years after baseline
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Mean physical performance (senior fitness battery) score
Time Frame: 1 year after baseline
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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:
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1 year after baseline
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Mean vegetable and Fruit Consumption in each group
Time Frame: 1 year after baseline
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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.
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1 year after baseline
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Mean plasma alpha carotene value in each group
Time Frame: 1 year after baseline
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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.
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1 year after baseline
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Mean rate of physical activity (self report via the CHAMPS and accelerometry
Time Frame: 1 year after baseline
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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.
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1 year after baseline
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Mean percent improvement on the Senior Fitness Battery test
Time Frame: 1 year post baseline
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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.
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1 year post baseline
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Mean percentage BMI score at 2 years post baseline
Time Frame: baseline to 2 years
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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.
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baseline to 2 years
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Mean Quality of Life (SF36) score at 2 years
Time Frame: 2 years after baseline
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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
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2 years after baseline
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Mean telomerase score in each group
Time Frame: 1 year post baseline
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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
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1 year post baseline
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Mean IL-6 and TNF alpha score in each arm
Time Frame: 1 year post baseline
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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)
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1 year post baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- site garden
- R01CA201362-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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