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

Cancer Survivor Clinical Trial

Official title:

Harvesting Health for Cancer Survivors: A Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268188
• Other study ID #: OSU-14013
• Secondary ID: NCI-2014-01498
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 31, 2015

Study information

• Verified date: August 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 31, 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor

Intervention

Other:
• education
Attend classes as part of Harvesting Health program
• 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

Other:
• questionnaire administration
Ancillary studies
• laboratory biomarker analysis
Correlative studies
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Life using the Short Form-12 (SF-12)	The SF-12 is a	Baseline to 6 months
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in nutrient intake	Viowell food frequency questionnaire	Baseline to 6 months

External Links

•   The Jamesline