Breast Cancer Clinical Trial
Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health
This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.
For this web-based behavioral intervention trial aimed at improving lifestyle behaviors of individuals at higher risk for cancer, other comorbidities and functional decline, 652 cancer survivors (a large proportion of whom will be age 65 or over, rural, and of minority status) will be enrolled and randomly assigned to one of the following study arms: 1) A diet and exercise intervention which would begin immediately, with the first 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, and the second 6 months focused on increasing physical activity. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; 2) An exercise and diet intervention which would begin immediately, with the first 6 months focused on increasing physical activity, and the second 6 months focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week. The 163 cancer survivors assigned to this arm would be evaluated at baseline, 6-, 12- and 18-months; and 3) A 12-month combined diet and exercise intervention focused on promoting healthful changes in diet consistent with the American Institute for Cancer Research Guidelines and designed to invoke an average weight loss of one pound per week, while at the same time promoting physical activity. The 326 cancer survivors assigned to this arm will be evaluated at baseline, 6-, 12-, and 18-months. Weight status, waist circumference, body composition, diet quality, physical activity, physical performance, quality of life, comorbidity, and health utilities will be measured at baseline and each follow-up time point, as will mediators of behavior change, e.g., social support, self-efficacy and barriers. Additionally, dried blood spots obtained from fingersticks will be analyzed for cytokines (IL-6 and hsCRP) and biomarkers of gluco- and lipid regulation, i.e., glucose, and blood lipids (TG) and insulin.
It is hypothesized that cancer survivors assigned to all three of these study arms will experience significant improvements in weight status, body composition, diet quality, physical activity, physical performance, and quality of life. These improvements also will translate into lower health utility scores and prove cost effective. It also is anticipated that analyses will uncover significant mediators, such as self-efficacy, and moderators, such as level of educational attainment associated with program efficacy. Finally, we hypothesize that while all study arms will experience significant benefit, the sequenced arm participants (arms 1 and 2) will have significantly greater odds of achieving improved diet quality, weight loss, and moderate intensity aerobic physical activity of at least 150 minutes a week as measured by accelerometer) post-intervention than survivors randomized to the simultaneous arm.
Age 50 years or older
Resident of the continental United States
Diagnosed with multiple myeloma, non-Hodgkin lymphoma, or localized kidney or ovarian cancer; or [localized (includes in situ) through regional] breast, colorectum, endometrium, thyroid, or prostate cancer.
Completed primary treatment (surgery, radiation or chemotherapy). Active surveillance among men with prostate cancer or women with ductal carcinoma in situ is acceptable.
Completion of the 8th grade of school. Able to read and write English.
Normal blood pressure or those with high blood pressure for whom physician permission was granted.
Reside in an area that receives wireless coverage.
Have an active email address or be willing to have one created for the study.
Current body mass index of greater than or equal to 25 kg/m2, but less than 50 kg/m2.
Current physical activity level is less than 150 minutes of moderate-to-vigorous exercise per week.
Participation in another diet and exercise program.
Evidence of progressive cancer of the eligible types.
Recurrence of the eligible cancer types (exceptions are biochemical recurrence of prostate cancer).
A physician has provided instruction to limit current physical activity.
Pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention (e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months).
Second primary cancers, with the exception of non-melanoma skin cancer, or if the initial and second cancers are both deemed eligible cancers.
Reside in a skilled nursing or assisted living facility.
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There are 2 Locations for this study
Birmingham Alabama, 35294, United States More Info
Memphis Tennessee, 38163, United States More Info
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