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Clinical Trials/NCT02985411
NCT02985411
Completed
Not Applicable

Harvest for Health in Older Cancer Survivors

University of Alabama at Birmingham1 site in 1 country381 target enrollmentOctober 1, 2016
ConditionsCancer Survivor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Survivor
Sponsor
University of Alabama at Birmingham
Enrollment
381
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
May 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wendy Demark-Wahnefried, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • Mean percent improvement on the Senior Fitness Battery test(1 year post baseline)
  • Mean vegetable and Fruit Consumption in each group(1 year after baseline)
  • Mean Quality of Life (SF36) score at 2 years(2 years after baseline)
  • Mean telomerase score in each group(1 year post baseline)
  • Mean Physical Functioning (SF36 physical function subscale) score in each group(1 years after baseline)
  • Mean rate of physical activity (self report via the CHAMPS and accelerometry(1 year after baseline)
  • Mean physical performance (senior fitness battery) score(1 year after baseline)
  • Mean plasma alpha carotene value in each group(1 year after baseline)
  • Mean percentage BMI score at 2 years post baseline(baseline to 2 years)
  • Mean IL-6 and TNF alpha score in each arm(1 year post baseline)

Study Sites (1)

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