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Web-Based Lifestyle Interventions for Cancer Survivor Health (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

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.

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

Must not have

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)

Evidence of progressive cancer of the eligible types

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for early-stage cancer survivors over 50, living in the US with a BMI of 25-50 kg/m2 and less than 150 minutes of exercise per week. They must have finished primary treatment, not be in another diet-exercise program, or have progressive/recurrent cancer. Those with severe health conditions that limit physical activity are excluded.

What is being tested?

The AMPLIFI Cancer Survivor Health study tests web-based interventions to improve diet and exercise among survivors of various cancers. It aims to see if these programs can enhance physical function, muscle mass, quality of life, and overall health.

What are the potential side effects?

As this trial focuses on lifestyle changes through diet and exercise interventions rather than medication, side effects may include typical exercise-related injuries or stress. Dietary changes could potentially cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of cancer listed.

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I have been diagnosed with a specific type of cancer, including multiple myeloma, non-Hodgkin lymphoma, or localized cancer in the kidney, ovary, breast, colorectum, endometrium, thyroid, or prostate.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that would stop me from following a weight loss plan on my own.

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My cancer is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in body weight

Change in dietary quality and intake (Patient reported outcome).

Change in physical activity and sleep (Measured by actigraphy)

Secondary study objectives

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 more

Other study objectives

Change in CIrculating Biomarkers

Change in Comorbidity and Symptoms (Patient reported outcome)

Change in Levels of Stress (Patient reported outcome)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met