<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985411</url>
  </required_header>
  <id_info>
    <org_study_id>site garden</org_study_id>
    <secondary_id>R01CA201362-01A1</secondary_id>
    <nct_id>NCT02985411</nct_id>
  </id_info>
  <brief_title>Harvest for Health in Older Cancer Survivors</brief_title>
  <official_title>Harvest for Health in Older Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Auburn University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gardening interventions yield a multitude of measurable benefits that are evaluable within&#xD;
      the context of a clinical trial. Harvest for Health forges new inroads in the delivery of&#xD;
      holistic interventions to high risk populations, in this case, older cancer survivors. Since&#xD;
      the intervention banks on an existing organization's infrastructure, it can easily be&#xD;
      disseminated nationwide. The next step is to prove efficacy - an essential step in&#xD;
      contributing to the science in this area, and one which is crucial for future dissemination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are roughly 15 million cancer survivors in the US, comprising 4% of the populace. The&#xD;
      number of cancer survivors is skyrocketing due to a confluence of the following factors: 1)&#xD;
      Americans are aging; 2) cancer is an age-related disease (&gt;60% of cancer survivors are age&#xD;
      65+); and 3) improvements in early detection and treatment have resulted in many common&#xD;
      cancers having 5-year cure rates that surpass 90%. Rising numbers of cancer survivors is good&#xD;
      news, but over $130 billion annually is needed to address subjects long-term health and&#xD;
      psychosocial needs.113 Compared to others, cancer survivors are at higher risk for other&#xD;
      cancers, CVD, osteoporosis, and diabetes. Accelerated functional decline also is a major&#xD;
      problem for cancer survivors, especially those who are older. Baker et al. found that&#xD;
      compared to age-matched controls, cancer cases (n=45,494) had significantly lower physical&#xD;
      and social functioning, vitality, mental health, and HRQoL (p&lt;0.001). Results of others are&#xD;
      similar and suggest that cancer survivors face functional decline that threatens subject&#xD;
      ability to live independently, posing a burden to themselves, subject families and the health&#xD;
      care system. Programs exist in land grant universities in all 50 United States. Certified MGs&#xD;
      complete &gt; 100 hrs. of training and community service (CS) and 25 hrs./year of CS to maintain&#xD;
      active status. In surveying 184 MGs in AL, the investigators found that 71% were &quot;extremely&#xD;
      interested&quot; in mentoring a cancer survivor on vegetable gardening for subject CS, and an&#xD;
      extra 26% stated that &quot;they were interested and wanted to learn more.&quot; Thus, the project is&#xD;
      of great interest and builds on an extant infrastructure for sustainability. Ultimately, this&#xD;
      intervention could be disseminated to states with 3 growing seasons and adapted to colder&#xD;
      weather in those with 2 growing seasons (36 states where 10.8 million older cancer survivors&#xD;
      reside). The intervention also could be adapted for persons with other chronic diseases in&#xD;
      which physical functioning and lifestyle behaviors are key. Finally, this project is&#xD;
      significant because the intervention has great potential for sustainability since gardening:&#xD;
      (a) involves many activities which prevent burn-out common with other forms of exercise, and&#xD;
      allows participants to pursue PA outdoors which is related to greater enjoyment; (b) provides&#xD;
      a sense of achievement and zest for life that come from nurturing and observing new life and&#xD;
      growth; and (c) imparts natural prompts since plants require regular care (watering) and&#xD;
      attention (harvesting) and serve as continual and dynamic behavioral cues.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">May 15, 2022</completion_date>
  <primary_completion_date type="Actual">May 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>1 year after baseline</time_frame>
    <description>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&#xD;
&gt;5-point increase on the Short Form 36 Physical Function subscale [SF36 PFSS] AND improvement on the Senior Fitness Battery&#xD;
Increase in intake of ½ c of vegetables and fruits/day AND increase is plasma alpha-carotene.&#xD;
Increase of &gt;30 minutes per week of moderate to vigorous physical activity AND confirmatory increase in physical activity as assessed by accelerometry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Physical Functioning (SF36 physical function subscale) score in each group</measure>
    <time_frame>1 years after baseline</time_frame>
    <description>The 10-item scale measures perceived limitations to various physical tasks in which the participant response &quot;limited a lot,&quot; &quot;limited a little&quot; or &quot;not limited at all&quot; (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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean physical performance (senior fitness battery) score</measure>
    <time_frame>1 year after baseline</time_frame>
    <description>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 &amp; Go). Each test is backed by age and gender appropriate population-based norms; cutpoints denoting high risk for low function are as follows:&#xD;
30-second chair stand: &lt;8 unassisted stands&#xD;
Arm curl: &lt;11 curls&#xD;
2-minute step test: &lt;65 steps&#xD;
Chair sit-and-reach: -4 cm in men and -2 cm in women&#xD;
Back scratch: -4 cm in men and -2 cm in women&#xD;
8 foot Get up and Go: &gt; 9 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean vegetable and Fruit Consumption in each group</measure>
    <time_frame>1 year after baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean plasma alpha carotene value in each group</measure>
    <time_frame>1 year after baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean rate of physical activity (self report via the CHAMPS and accelerometry</measure>
    <time_frame>1 year after baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean percent improvement on the Senior Fitness Battery test</measure>
    <time_frame>1 year post baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean percentage BMI score at 2 years post baseline</measure>
    <time_frame>baseline to 2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Quality of Life (SF36) score at 2 years</measure>
    <time_frame>2 years after baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean telomerase score in each group</measure>
    <time_frame>1 year post baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean IL-6 and TNF alpha score in each arm</measure>
    <time_frame>1 year post baseline</time_frame>
    <description>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 &lt;1.47)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">381</enrollment>
  <condition>Cancer Survivor</condition>
  <arm_group>
    <arm_group_label>Immediate Gardening Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wait-listed, will receive the gardening intervention after a 1-year period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Gardening Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals in this group will serve as their own control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Immediate Gardening Intervention</intervention_name>
    <description>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,</description>
    <arm_group_label>Immediate Gardening Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delayed Gardening Intervention</intervention_name>
    <description>Subjects will be monitored for 1-year and will then receive the same vegetable gardening intervention as described under the Immediate Gardening Intervention</description>
    <arm_group_label>Delayed Gardening Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residence in the following counties in Alabama: Autauga, Baldwin, Blount, Calhoun,&#xD;
             Cherokee, Chilton, Coffee, Cullman, Dale, Dekalb, Elmore, Etowah. Houston, Jackson,&#xD;
             Jefferson, Lauderdale, Lee, Limestone, Madison, Marshall, Mobile, Morgan, Montgomery,&#xD;
             Pike, Randolph, Shelby, St. Clair, Tallapoosa, Tuscaloosa, Walker&#xD;
&#xD;
          -  Diagnosed with one of the following cancers and completed primary treatment: localized&#xD;
             larynx, gastric cardia, or cervix; localized or regionally-staged bladder, colorectum,&#xD;
             fallopian tube, breast (female only), kidney and renal, melanoma, oral cavity, ovary,&#xD;
             pharynx, prostate, soft tissue sarcoma, thyroid or uterus; or all stages: Hodgkin or&#xD;
             Non-Hodgkin Lymphoma, Leukemia (CML CLL ALL) or testis.&#xD;
&#xD;
          -  has at least one physical function limitation as measured by the SF-36 physical&#xD;
             function subscale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently tends an in-ground vegetable garden year round.&#xD;
&#xD;
          -  Currently eats at least 2.5 cups of fruits and vegetable/day&#xD;
&#xD;
          -  Currently obtains 150 or more of moderate-to-vigorous exercise per week&#xD;
&#xD;
          -  Has a medical condition that precludes safe pursuit of gardening, i.e., severe&#xD;
             orthopedic conditions, pending hip/knee replacement (within 6 mo.), paralysis,&#xD;
             dementia, blindness, untreated stage 3 hypertension, or myocardial infarction,&#xD;
             congestive heart failure, or conditions that required oxygen or hospitalization within&#xD;
             6 mo.&#xD;
&#xD;
          -  unsuitable residence for gardening, i.e., no running water, inadequate sunshine.&#xD;
&#xD;
          -  not able to speak or read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy Demark-Wahnefried, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27565830</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23438359</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29305129</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29932460</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Wendy Demark-Wahnefried, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will not share data until study is complete and all data deidentified</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985411
org study id: site garden
secondary id: R01CA201362-01A1
nct id: NCT02985411
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
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
description: 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.
measure: Mean Physical Functioning (SF36 physical function subscale) score in each group
time frame: 1 years after baseline
description: 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
measure: Mean physical performance (senior fitness battery) score
time frame: 1 year after baseline
description: 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
measure: Mean vegetable and Fruit Consumption in each group
time frame: 1 year after baseline
description: 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.
measure: Mean plasma alpha carotene value in each group
time frame: 1 year after baseline
description: 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.
measure: Mean rate of physical activity (self report via the CHAMPS and accelerometry
time frame: 1 year after baseline
description: 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.
measure: Mean percent improvement on the Senior Fitness Battery test
time frame: 1 year post baseline
description: 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.
measure: Mean percentage BMI score at 2 years post baseline
time frame: baseline to 2 years
description: 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.
measure: Mean Quality of Life (SF36) score at 2 years
time frame: 2 years after baseline
description: 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
measure: Mean telomerase score in each group
time frame: 1 year post baseline
description: 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
measure: Mean IL-6 and TNF alpha score in each arm
time frame: 1 year post baseline
description: 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)
arm group label: Immediate Gardening Intervention
arm group type: Active Comparator
description: Wait-listed, will receive the gardening intervention after a 1-year period
arm group label: Delayed Gardening Intervention
arm group type: Active Comparator
description: Individuals in this group will serve as their own control
intervention type: Behavioral
intervention name: Immediate Gardening Intervention
description: 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,
arm group label: Immediate Gardening Intervention
intervention type: Other
intervention name: Delayed Gardening Intervention
description: Subjects will be monitored for 1-year and will then receive the same vegetable gardening intervention as described under the Immediate Gardening Intervention
arm group label: Delayed Gardening Intervention
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Wendy Demark-Wahnefried, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Wendy Demark-Wahnefried, PhD
investigator title: Principal Investigator
sharing ipd: No
ipd description: Will not share data until study is complete and all data deidentified