Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
NCT Number: NCT02268188
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attend classes as part of Harvesting Health program
Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program
Use FitBit to log daily steps as part of Harvesting Health program
Ancillary studies
Correlative studies
Ancillary studies
Other names: quality of life assessment
Time frame: Up to 6 months
Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.
Time frame: Up to 12 months
Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.
Time frame: Up to 12 months
Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.
Time frame: Up to 20 weeks
Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.
Time frame: Baseline to 12 months
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 components of these Scorecards are driving the improvement or degradation in scores.
Time frame: Baseline to 6 months
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 Hotelling's T-squared test at the 0.05 level. If a significant difference is noted, then the individual scores will be further tested with paired t-tests to determine which are significantly different. The p-values of the individual t-tests will be adjusted via a Bonferroni correction.
Time frame: Baseline to 12 months
This questionnaire categorizes respondents into "Low", "Moderate", or "High" activity levels based upon survey responses.
Time frame: Baseline to 6 months
Viowell food frequency questionnaire
Time frame: Baseline to 6 months
The SF-12 is a
Time frame: Baseline to 6 months
The CED-R is a screening test for depression and depressive disorder. The range of scores is between 0 and 60 and a score over 16 indicates depression.
Ohio State University Comprehensive Cancer Center
Other
Harvesting Health for Cancer Survivors: A Pilot Project
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06894849
Cancer, Cancer Survivor
Charleston, South Carolina, United States
View Trial DetailsNCT04251299
Cancer Survivor
Albuquerque, New Mexico, United States
View Trial DetailsNCT06809452
Cancer Survivor
Assen, Drenthe, Netherlands
View Trial DetailsNCT06398782
Body Composition, Cancer Survivor
View Trial Details