Harvesting Health for Cancer Survivors: A Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Percentage of sessions attended, as measured by mobile scanner
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: nutrition intervention (Other)
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.
干预措施: laboratory biomarker analysis (Other)
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.
干预措施: quality-of-life assessment (Other)
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.
干预措施: questionnaire administration (Other)
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.
干预措施: education (Other)
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.
干预措施: exercise intervention (Behavioral)
结局指标
主要结局
Percentage of sessions attended, as measured by mobile scanner
时间窗: Up to 6 months
Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.
Number of hits on the web portal
时间窗: Up to 12 months
Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.
次要结局
- Program evaluation overall score(Up to 20 weeks)
- Number of web hits on portal pages(Up to 12 months)
- Change in nutrient intake(Baseline to 6 months)
- Change in behavior, measured by Nutrition & Physical Activity Scorecards(Baseline to 12 months)
- Change in biomarker levels, assessed by values for the Health & Wellness Index(Baseline to 6 months)
- Change in physical activity using the International Physical Activity Questionnaire(Baseline to 12 months)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center