Clinical trial NCT02268188: Harvesting Health Program in Improving Diet and Physical Activity Level in Cancer Survivors
Official title: Harvesting Health for Cancer Survivors: A Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Keywords: Cancer Survivors
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of sessions attended, as measured by mobile scanner
timeFrame: Up to 6 months
measure: Number of hits on the web portal
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of web hits on portal pages
timeFrame: Up to 12 months
measure: Program evaluation overall score
timeFrame: Up to 20 weeks
measure: Change in behavior, measured by Nutrition & Physical Activity Scorecards
timeFrame: Baseline to 12 months
measure: Change in biomarker levels, assessed by values for the Health & Wellness Index
timeFrame: Baseline to 6 months
measure: Change in physical activity using the International Physical Activity Questionnaire
timeFrame: Baseline to 12 months
measure: Change in nutrient intake
timeFrame: Baseline to 6 months
Other outcomes:
measure: Change in Quality of Life using the Short Form-12 (SF-12)
timeFrame: Baseline to 6 months
measure: Change in depression scale using the Center for Epidemiologic Studies Depression Scale Revised (CED-R)
timeFrame: Baseline to 6 months
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Steven Clinton
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.