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Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

OSU-14013


NCT ID:

NCT02268188


Secondary ID:

NCI-2014-01498


Study Acronym:


Brief Title:

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


Official Title:

Harvesting Health for Cancer Survivors: A Pilot Project


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center

Study Dates

Start Date:April 2014
Completion Date:October 31, 2015
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 29, 2019
First Received Date:October 15, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of sessions attended, as measured by mobile scanner
Time Frame:Up to 6 months
Safety Issues:False
Description:Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.
Outcome Type:Secondary Outcome
Measure:Change in nutrient intake
Time Frame:Baseline to 6 months
Safety Issues:False
Description:Viowell food frequency questionnaire
Outcome Type:Secondary Outcome
Measure:Change in physical activity using the International Physical Activity Questionnaire
Time Frame:Baseline to 12 months
Safety Issues:False
Description:This questionnaire categorizes respondents into "Low", "Moderate", or "High" activity levels based upon survey responses.
Outcome Type:Secondary Outcome
Measure:Change in biomarker levels, assessed by values for the Health & Wellness Index
Time Frame:Baseline to 6 months
Safety Issues:False
Description:Biomarkers include blood glucose, lipid panel (total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides), skin antioxidant score and bone density. The hypothesis of no change in these markers will be tested using a multivariate
Outcome Type:Secondary Outcome
Measure:Change in behavior, measured by Nutrition & Physical Activity Scorecards
Time Frame:Baseline to 12 months
Safety Issues:False
Description:The hypothesis of no change in the overall scorecard value will be tested versus a two sided alternative using a paired T-test at alpha level 0.025 (Bonferroni corrected for 2 scorecards). Exploratory analyses may be completed to understand which componen
Outcome Type:Secondary Outcome
Measure:Program evaluation overall score
Time Frame:Up to 20 weeks
Safety Issues:False
Description:Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.
Outcome Type:Secondary Outcome
Measure:Number of web hits on portal pages
Time Frame:Up to 12 months
Safety Issues:False
Description:Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.
Outcome Type:Primary Outcome
Measure:Number of hits on the web portal
Time Frame:Up to 12 months
Safety Issues:False
Description:Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.

Study Interventions

Intervention Type:Other
Name:education
Description:Attend classes as part of Harvesting Health program
Arm Name:Supportive Care (Harvesting Health program)
Intervention Type:Other
Name:nutrition intervention
Description:Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program
Arm Name:Supportive Care (Harvesting Health program)
Intervention Type:Behavioral
Name:exercise intervention
Description:Use FitBit to log daily steps as part of Harvesting Health program
Arm Name:Supportive Care (Harvesting Health program)
Intervention Type:Other
Name:questionnaire administration
Description:Ancillary studies
Arm Name:Supportive Care (Harvesting Health program)
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Supportive Care (Harvesting Health program)
Intervention Type:Other
Name:quality-of-life assessment
Description:Ancillary studies
Arm Name:Supportive Care (Harvesting Health program)
Other Name:quality of life assessment

Study Arms

Study Arm Type:Experimental
Arm Name:Supportive Care (Harvesting Health program)
Description: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. The guidelines described in class are part of a nutrition intervention and an exercise intervention with personal and group goal setting over the course of the study.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University Comprehensive Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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