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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: questionnaire administration; Other: quality-of-life assessment; Other: education; Other: nutrition intervention; Behavioral: exercise intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Care (Harvesting Health program); 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.

Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: education; Attend classes as part of Harvesting Health program; Other: nutrition intervention; Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program; Behavioral: exercise intervention; Use FitBit to log daily steps as part of Harvesting Health program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 31, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cancer Survivors
• Other Study ID Numbers: OSU-14013; NCI-2014-01498 (Registry Identifier: CTRP (Clinical Trial Reporting Program))