Cancer Survivor Clinical Trial
Official title:
Harvest for Health in Older Cancer Survivors
Verified date | June 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Gardening interventions yield a multitude of measurable benefits that are evaluable within the context of a clinical trial. Harvest for Health forges new inroads in the delivery of holistic interventions to high risk populations, in this case, older cancer survivors. Since the intervention banks on an existing organization's infrastructure, it can easily be disseminated nationwide. The next step is to prove efficacy - an essential step in contributing to the science in this area, and one which is crucial for future dissemination.
Status | Completed |
Enrollment | 381 |
Est. completion date | May 15, 2022 |
Est. primary completion date | May 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Residence in the following counties in Alabama: Autauga, Baldwin, Blount, Calhoun, Cherokee, Chilton, Coffee, Cullman, Dale, Dekalb, Elmore, Etowah. Houston, Jackson, Jefferson, Lauderdale, Lee, Limestone, Madison, Marshall, Mobile, Morgan, Montgomery, Pike, Randolph, Shelby, St. Clair, Tallapoosa, Tuscaloosa, Walker - Diagnosed with one of the following cancers and completed primary treatment: localized larynx, gastric cardia, or cervix; localized or regionally-staged bladder, colorectum, fallopian tube, breast (female only), kidney and renal, melanoma, oral cavity, ovary, pharynx, prostate, soft tissue sarcoma, thyroid or uterus; or all stages: Hodgkin or Non-Hodgkin Lymphoma, Leukemia (CML CLL ALL) or testis. - has at least one physical function limitation as measured by the SF-36 physical function subscale. Exclusion Criteria: - Currently tends an in-ground vegetable garden year round. - Currently eats at least 2.5 cups of fruits and vegetable/day - Currently obtains 150 or more of moderate-to-vigorous exercise per week - Has a medical condition that precludes safe pursuit of gardening, i.e., severe orthopedic conditions, pending hip/knee replacement (within 6 mo.), paralysis, dementia, blindness, untreated stage 3 hypertension, or myocardial infarction, congestive heart failure, or conditions that required oxygen or hospitalization within 6 mo. - unsuitable residence for gardening, i.e., no running water, inadequate sunshine. - not able to speak or read English |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Auburn University, National Cancer Institute (NCI) |
United States,
Bail JR, Fruge AD, Cases MG, De Los Santos JF, Locher JL, Smith KP, Cantor AB, Cohen HJ, Demark-Wahnefried W. A home-based mentored vegetable gardening intervention demonstrates feasibility and improvements in physical activity and performance among breast cancer survivors. Cancer. 2018 Aug;124(16):3427-3435. doi: 10.1002/cncr.31559. Epub 2018 Jun 22. — View Citation
Blair CK, Madan-Swain A, Locher JL, Desmond RA, de Los Santos J, Affuso O, Glover T, Smith K, Carley J, Lipsitz M, Sharma A, Krontiras H, Cantor A, Demark-Wahnefried W. Harvest for health gardening intervention feasibility study in cancer survivors. Acta Oncol. 2013 Aug;52(6):1110-8. doi: 10.3109/0284186X.2013.770165. Epub 2013 Feb 26. — View Citation
Cases MG, Fruge AD, De Los Santos JF, Locher JL, Cantor AB, Smith KP, Glover TA, Cohen HJ, Daniel M, Morrow CD, Moellering DR, Demark-Wahnefried W. Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors. Contemp Clin Trials. 2016 Sep;50:201-12. doi: 10.1016/j.cct.2016.08.014. Epub 2016 Aug 23. — View Citation
Demark-Wahnefried W, Cases MG, Cantor AB, Fruge AD, Smith KP, Locher J, Cohen HJ, Tsuruta Y, Daniel M, Kala R, De Los Santos JF. Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity. J Acad Nutr Diet. 2018 Apr;118(4):689-704. doi: 10.1016/j.jand.2017.11.001. Epub 2018 Jan 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of subjects in each group at year 1 who meet ALL 3 of 3 of the following goals: Physical performance tests, plasma a-carotene, and accelerometry-measured physical exam | Percent of subjects in each group at year 1 who meet ALL 3 of 3 of the following goals: Physical performance tests, plasma a-carotene, and accelerometry-measured PA
>5-point increase on the Short Form 36 Physical Function subscale [SF36 PFSS] AND improvement on the Senior Fitness Battery Increase in intake of ½ c of vegetables and fruits/day AND increase is plasma alpha-carotene. Increase of >30 minutes per week of moderate to vigorous physical activity AND confirmatory increase in physical activity as assessed by accelerometry. |
1 year after baseline | |
Secondary | Mean Physical Functioning (SF36 physical function subscale) score in each group | The 10-item scale measures perceived limitations to various physical tasks in which the participant response "limited a lot," "limited a little" or "not limited at all" (A 3-point scale is used and the score is transformed to a 0-100 point scale in which a score of 50 reflects an average score (with a 100 reflecting no limitations and 0 means severe limitations in multiple domains | 1 years after baseline | |
Secondary | Mean physical performance (senior fitness battery) score | The Senior Fitness Test Battery tests several physical function domains: i.e., lower and upper body strength (using the 30-second chair stand and arm curl), endurance (using the 2-minute step test), flexibility (using the chair sit-and-reach and back scratch), and agility/dynamic balance (using the 8-ft Get Up & Go). Each test is backed by age and gender appropriate population-based norms; cutpoints denoting high risk for low function are as follows:
30-second chair stand: <8 unassisted stands Arm curl: <11 curls 2-minute step test: <65 steps Chair sit-and-reach: -4 cm in men and -2 cm in women Back scratch: -4 cm in men and -2 cm in women 8 foot Get up and Go: > 9 seconds |
1 year after baseline | |
Secondary | Mean vegetable and Fruit Consumption in each group | The number of daily ½ cup servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals meet the goal (2.5 cups per day) or not. | 1 year after baseline | |
Secondary | Mean plasma alpha carotene value in each group | Plasma a-carotene will be quantified via high-performance liquid chromatography methods using a Hitachi 911clinical analyzer with standard chemistries by Roche (Indianapolis, IN). The range of a-Carotene varies from 0.1 to 0.90 µmol/ with a mean score of 0.5. This test is conducted for research purposes only. Thus, while a range between 0.50 and 0.90 is desirable, there are no clinically agreed guidelines to provide patients with information on lower levels. | 1 year after baseline | |
Secondary | Mean rate of physical activity (self report via the CHAMPS and accelerometry | Physical activity will be measured via self-report, using the Community Healthy Activities Models Program for Seniors (CHAMPS), a validated and sensitive tool that captures physical activities specific to older adults. This instrument will be used to assess minutes of moderate to vigorous activity per week. Objective levels of physical activity, will be captured via accelerometry. All participants will be asked to wear an activity monitor on their waist for 7 days at baseline, 1- and 2- year follow-up. Readings obtained from accelerometry also will be used to assess the minutes of moderate to vigorous physical activity. | 1 year after baseline | |
Secondary | Mean percent improvement on the Senior Fitness Battery test | Change from baseline to 1-year follow-up in each measure of physical performance will be compared between those in the immediate vs. delayed intervention groups at 1-year. | 1 year post baseline | |
Secondary | Mean percentage BMI score at 2 years post baseline | An improved diet and improved physical activity is associated with a weight status within the normal range, we will assess changes in weight status over the study period by measuring height (at baseline), and weight (using a platform scale) at all timepoints. Weights and heights will be converted to MI (KG/M2). The percentage of each study arm categorized as normal weight (BMI 18.5 - 24.9) at each time point. | baseline to 2 years | |
Secondary | Mean Quality of Life (SF36) score at 2 years | The SF-36 offers scores for mental health and physical health. These scores are each transformed to a 0-100 point scale in which a score of 50 reflects an average score (with a 100 reflecting optimal status and 0 meaning severly compromised (minimal) status | 2 years after baseline | |
Secondary | Mean telomerase score in each group | PENDING RECEIPT OF ANCILLARY FUNDING: Telomerase activity will be measured in blood sample buffy coats using the Telomerase PCR ELISA assay (Boehringer Mannheim). While many individuals will express non-detectable levels, the percentage of individuals who have optimal levels of 0.20-1.5 will be compared in each arm | 1 year post baseline | |
Secondary | Mean IL-6 and TNF alpha score in each arm | IL-6 will be assessed IN PLASMA via electrochemiluminescence (Meso-scale Discovery; Gaithersburg, MD). AN ANTICIPATED RANGE OF 0.015 to 11.5 pg/ml IS ANTICIPATED, WITH LOWER LEVELS INDICATING LESS INFLAMMATION AND LOWER RISK FOR CHRONIC DISEASE (VALUES <1.47) | 1 year post baseline |
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