NCT04000880

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health

Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Endometrial Cancer
• Kidney Cancer
• Multiple Myeloma
• Ovary Cancer
• Prostate Cancer
• Thyroid Cancer
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BEHAVIORAL	Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health	AMPLIFI will provide participants with a secure website where they receive and participate in educational sessions tailored to their assigned topics for the intervention arm. The website will provide a resource library for static documents, tips of the day, tracking of health behaviors, and goal-setting.
OTHER	Diet-Exercise	Diet-Exercise
OTHER	Exercise-Diet	Exercise-Diet
OTHER	Combined Diet and Exercise	Combined Diet and Exercise

Timeline

• Start date: 2020-03-04
• Primary completion: 2025-04-01
• Completion: 2025-09-01
• First posted: 2019-06-27
• Last updated: 2025-06-12

Locations

2 sites across 1 country: United States