Overview

This trial is active, not recruiting.

Condition cancer survivor
Treatments educational intervention, nutritional intervention, exercise intervention, questionnaire administration, laboratory biomarker analysis, quality-of-life assessment
Sponsor Ohio State University Comprehensive Cancer Center
Start date April 2014
End date April 2017
Trial size 50 participants
Trial identifier NCT02268188, NCI-2014-01498, OSU-14013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(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.
educational intervention intervention, educational
Undergo Harvesting Health program
nutritional intervention
Undergo Harvesting Health program
exercise intervention
Undergo Harvesting Health program
questionnaire administration
Ancillary studies
laboratory biomarker analysis
Correlative studies
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Percentage of sessions attended, as measured by mobile scanner
time frame: Up to 6 months
Number of hits on the web portal
time frame: Up to 12 months

Secondary Outcomes

Measure
Number of web hits on portal pages
time frame: Up to 12 months
Program evaluation overall score
time frame: Up to 20 weeks
Change in behavior, measured by Nutrition & Physical Activity Scorecards
time frame: Baseline to 12 months
Change in biomarker levels, assessed by values for the Health & Wellness Index
time frame: Baseline to 6 months
Program sustainability, measured by change in questionnaire scores
time frame: Baseline to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Harvesting Health for Cancer Survivors: A Pilot Project
Principal investigator Steven Clinton
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.