NCT02969577

Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Detailed description

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy). Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT: 1. Staying Strong \& Healthy Intervention + Usual Care 2. Usual Care All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong \& Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Program	Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
BEHAVIORAL	Diet and Nutrition Coaching	Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
OTHER	Usual Care with Attention	Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

Timeline

• Start date: 2017-03-07
• Primary completion: 2020-07-01
• Completion: 2020-07-31
• First posted: 2016-11-21
• Last updated: 2021-02-17

Locations

2 sites across 1 country: United States