Harvesting Health Program in Improving Diet and Physical Activity Level in Cancer Survivors



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:April 2014
End Date:April 2019

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Harvesting Health for Cancer Survivors: A Pilot Project

This pilot clinical trial studies the Harvesting Health Program in improving the diet and
physical activity level of cancer survivors. Nutrition and physical activity classes and the
opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and
vegetable consumption and physical activity levels. Studying the participation rates and
changes in participants' eating and physical activity habits may help doctors learn whether
the program has an effect on participant lifestyle.

PRIMARY OBJECTIVES:

I. Measure survivor participation in regards to each aspect of the Harvesting Health Program
(personalized and group education, gardening and harvesting, and utilization of novel
web-based technologies).

II. Assess survivor preferences regarding key Harvesting Health Program components impacting
participation (physical facilities, schedule and timing, education topics and sessions,
garden access, web portal usability, etc.).

SECONDARY OBJECTIVES:

I. A customized "Nutrition & Physical Activity Scorecard" has been developed and will be
implemented to evaluate pre/post measures of diet and physical activity at baseline (month 0)
and at months 6, 9 and 12.

II. Participants are evaluated at baseline and at completion of the intervention for: (a)
serum and body composition biomarkers of exposure and efficacy, and (b) health indices
related to cancer survivorship and overall health.

III. To assess Program sustainability, follow-up questionnaires will be completed at 9 and 12
months using the Nutrition & Physical Activity Scorecard and questionnaires regarding quality
of life outcomes.

OUTLINE:

Participants undergo a series of 10 education and training sessions over 1 hour every 2
weeks, comprising education on current research, evidence-based health guidelines,
application techniques, reference materials specific to extended-stage cancer survivors, and
recommendations and personal health goals for survivorship.

Inclusion Criteria:

- Voluntary agreement to participate and sign an informed consent document

- Adults with the ability to read, write, and speak English who have access to the
internet

- Cancer survivors who have completed active cancer treatments within the previous 12
months extended-stage survivors)

- Survivors must have a computer with internet access and an active email account

- Participants must refrain from traveling for more than 3 weeks total during the
intervention period

- Participants who are undergoing long-term hormone therapy (i.e., tamoxifen) are
permitted to enroll

Exclusion Criteria:

- Cancer survivors who are cognitively unable to consent or have physical or mental
limitations that would prevent full participation in the program

- Adults receiving active treatment including surgery, neoadjuvant hormonal,
chemotherapy, or radiation

- Survivors with pre-existing medical conditions that preclude unsupervised physical
activity (i.e., severe orthopedic conditions, impending hip or knee replacement,
paralysis, unstable angina, dementia, or recent history of myocardial infarction,
congestive heart failure, pulmonary conditions that require oxygen, or hospitalization
within six months)

- Adults taking any medication that do not allow for increased intake of fruits and
vegetables (i.e., pharmacologic doses of warfarin)

- Survivors currently involved in other clinical trials

- Long-term cancer survivors (> 12 months post treatment)

- Those planning to start certain medications after the trial enrollment or use of non-
prescription substances (i.e. saw palmetto and other herbal or alternative products)

- Survivors with active metabolic or digestive illnesses such as malabsorptive disorders
(Crohn's, celiac disease, irritable bowel syndrome [IBS]), renal insufficiency,
hepatic insufficiency, cachexia, or short bowel syndrome

- Pregnant women will be excluded from the study
We found this trial at
1
site
300 W 10th Ave
Columbus, Ohio 43210
(800) 293-5066
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
?
mi
from
Columbus, OH
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