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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01498 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (Harvesting Health program) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education | Other | Attend classes as part of Harvesting Health program |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of sessions attended, as measured by mobile scanner | Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported. | Up to 6 months |
| Number of hits on the web portal | Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of web hits on portal pages | Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants. | Up to 12 months |
| Program evaluation overall score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life using the Short Form-12 (SF-12) | The SF-12 is a | Baseline to 6 months |
| Change in depression scale using the Center for Epidemiologic Studies Depression Scale Revised (CED-R) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31871455 | Derived | Spees CK, Braun AC, Hill EB, Grainger EM, Portner J, Young GS, Kleinhenz MD, Chitchumroonchokchai C, Clinton SK. Impact of a Tailored Nutrition and Lifestyle Intervention for Overweight Cancer Survivors on Dietary Patterns, Physical Activity, Quality of Life, and Cardiometabolic Profiles. J Oncol. 2019 Nov 21;2019:1503195. doi: 10.1155/2019/1503195. eCollection 2019. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| nutrition intervention | Other | Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program |
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| exercise intervention | Behavioral | Use FitBit to log daily steps as part of Harvesting Health program |
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| questionnaire administration | Other | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| quality-of-life assessment | Other | Ancillary studies |
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Quantitative and qualitative analysis will be performed on the harvest log to determine common themes and feedback from the participants.
| Up to 20 weeks |
| Change in behavior, measured by Nutrition & Physical Activity Scorecards | 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. | Baseline to 12 months |
| Change in biomarker levels, assessed by values for the Health & Wellness Index | 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. | Baseline to 6 months |
| Change in physical activity using the International Physical Activity Questionnaire | This questionnaire categorizes respondents into "Low", "Moderate", or "High" activity levels based upon survey responses. | Baseline to 12 months |
| Change in nutrient intake | Viowell food frequency questionnaire | Baseline to 6 months |
| Baseline to 6 months |
| ID | Term |
|---|---|
| D004522 | Educational Status |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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