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

The Ohio State University

Status: Completed

Conditions: Cancer Survivor

Treatments: Other: quality-of-life assessment; Other: questionnaire administration; Other: nutrition intervention; Behavioral: exercise intervention; Other: education; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02268188

OSU-14013

NCI-2014-01498 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Supportive Care (Harvesting Health program)

Experimental group

Description:

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.

Treatment:

Other: education

Other: laboratory biomarker analysis

Behavioral: exercise intervention

Other: nutrition intervention

Other: quality-of-life assessment

Other: questionnaire administration