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Diet-Exercise for Thyroid Cancer(AMPLIFY Trial)
N/A
Waitlist Available
Led By Wendy Demark-Wahnefried, PhD, RD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal blood pressure or those with high blood pressure for whom physician permission was granted
Community dwelling
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 months
Awards & highlights
No Placebo-Only Group
AMPLIFY Trial Summary
This trial will test whether web-based interventions can help cancer survivors make healthier lifestyle choices. Outcomes include things like weight management and quality of life.
Eligible Conditions
- Thyroid Cancer
- Prostate Cancer
- Multiple Myeloma
- Non-Hodgkin's Lymphoma
- Breast Cancer
- Endometrial Cancer
- Colorectal Cancer
- Ovarian Cancer
- Kidney Cancer
AMPLIFY Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have normal blood pressure, or if you have high blood pressure, your doctor has given permission for you to participate.
Select...
You live in your own home or in the community, not in a care facility.
Select...
You are 50 years old or older.
Select...
Your body mass index (BMI) is between 25 and 50.
Select...
You have been diagnosed with certain types of cancer in specific areas of the body.
Select...
You have finished your main treatment for cancer. If you have prostate cancer or ductal carcinoma in situ, it's okay if you're still being watched closely by your doctor.
Select...
You do not engage in at least 150 minutes of moderate-to-vigorous exercise per week.
AMPLIFY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in body weight
Change in dietary quality and intake (Patient reported outcome).
Change in physical activity and sleep (Measured by actigraphy)
Secondary outcome measures
Change in healthcare utilization (Patient reported outcome)
Change in muscle mass (Measured by the D3 creatine dilution method)
Change in physical activity (Patient reported outcome)
+3 moreOther outcome measures
Change in CIrculating Biomarkers
Change in Comorbidity and Symptoms (Patient reported outcome)
Change in Levels of Stress (Patient reported outcome)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
AMPLIFY Trial Design
3Treatment groups
Experimental Treatment
Group I: Project 3: Combined Diet and ExerciseExperimental Treatment3 Interventions
Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Group II: Project 2: Exercise-DietExperimental Treatment2 Interventions
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Group III: Project 1: Diet-ExerciseExperimental Treatment2 Interventions
Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,523 Previous Clinical Trials
2,258,835 Total Patients Enrolled
University of TennesseeOTHER
188 Previous Clinical Trials
141,474 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,487 Previous Clinical Trials
41,266,129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not exercise for at least 150 minutes per week at a moderate-to-vigorous level.You live in the community, not in a care facility.You live in your own home or a place in the community.You are able to read and write English.\nYou are currently involved in another diet and exercise program.Your cancer is getting worse.You have normal blood pressure, or if you have high blood pressure, your doctor has given permission for you to participate.You live in your own home or in the community, not in a care facility.You have medical conditions that make it difficult for you to follow a weight loss plan without supervision, such as being pregnant, having severe joint problems, or recent serious heart or lung issues.You are 50 years old or older.You are 50 years old or older.Men with prostate cancer or women with ductal carcinoma in situ are eligible for active surveillance.You live in an area that has cell phone or Wi-Fi signal.Your body mass index (BMI) is between 25 and 50.Your cancer has come back, except if you have a specific type of recurrence in prostate cancer.You have either normal blood pressure or high blood pressure with permission from your doctor.You have been diagnosed with certain types of cancer in specific areas of the body.You do not engage in at least 150 minutes of moderate-to-vigorous exercise per week.You have had more than one type of cancer, except for non-melanoma skin cancer, unless both types are the same kind of cancer.You have been diagnosed with certain types of cancer, including multiple myeloma, non-Hodgkin lymphoma, kidney or ovarian cancer that has not spread, or specific types of breast, colorectal, endometrial, thyroid, or prostate cancer.You have finished your main treatment for cancer. If you have prostate cancer or ductal carcinoma in situ, it's okay if you're still being watched closely by your doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Project 1: Diet-Exercise
- Group 2: Project 3: Combined Diet and Exercise
- Group 3: Project 2: Exercise-Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate purpose of this investigation?
"This 30-month long study aims to measure a subject's body weight change. Secondary outcomes will include changes in waist circumference (measured with an unmarked tape placed at the umbilicus), muscle mass (assessed through ingestion of deuterium-labeled creatine and subsequent urine testing) as well as physical performance, which is tested using the Senior Fitness Battery that includes chair stands, 3m walks, 8' up and go tests, balance assessments of side-by-side, semi-tandem and tandem stances along with arm/leg stretching exercises and 2 minute step tests."
Answered by AI
Can you provide an estimate of how many individuals are participating in this experiment?
"Affirmative. According to the information provided on clinicaltrials.gov, this trial is currently recruiting participants and began its search for 652 people from two sites on March 4th 2020 with a most recent update occurring February 8th 2022."
Answered by AI
Are there any vacancies left to participate in this research project?
"Patient recruitment for this medical study is ongoing. It has been in progress since the 4th of March 2020, with its last update occurring on the 8th of February 2022."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Alabama at Birmingham
University of Tennessee Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
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