Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: Exercise ProgramOther: Usual Care with AttentionBehavioral: Diet and Nutrition Coaching
- Registration Number
- NCT02969577
- Lead Sponsor
- University of Kansas Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 38
- Diagnosed with prostate cancer
- Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
- Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
- Able to speak and read in English or Spanish
- Reachable consistently by telephone
- Able to travel to KUMC
- Not diagnosed with prostate cancer
- Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
- Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
- Not able to speak and read in English or Spanish
- Not reachable consistently by telephone
- Not able to travel to the study site for data collection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Staying Strong & Healthy Intervention (SS&H) Exercise Program Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study. Usual Care with Attention (UCA) Usual Care with Attention Participants will receive the usual care they would normally receive if not taking part in this study. Staying Strong & Healthy Intervention (SS&H) Diet and Nutrition Coaching Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study. Staying Strong & Healthy Intervention (SS&H) Usual Care with Attention Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.
- Primary Outcome Measures
Name Time Method Change in LDL Change from Baseline to Month 12
- Secondary Outcome Measures
Name Time Method Change in Body Mass Index (BMI) Change from Baseline to Month 12 Change in Lipid Profile Change from Baseline to Month 12 Change in Health Related Quality Change from Baseline to Month 12 Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
Change in Glucose Change from Baseline to Month 12 Change in Waist/Hip Circumference Change from Baseline to Month 12
Trial Locations
- Locations (2)
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States