Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NR014518 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staying Strong & Healthy Intervention (SS&H) | Experimental | 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) | Active Comparator | Participants will receive the usual care they would normally receive if not taking part in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL | Change from Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | Change from Baseline to Month 6 | |
| Change in Body Mass Index (BMI) | Change from Baseline to Month 12 | |
| Change in Lipid Profile |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sally Maliski, PhD, RN, FAAN | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of Kansas Medical Center |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D004032 | Diet |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Diet and Nutrition Coaching | Behavioral | 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. |
|
| Usual Care with Attention | Other | 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. |
|
| Change from Baseline to Month 6 |
| Change in Lipid Profile | Change from Baseline to Month 12 |
| Change in Waist/Hip Circumference | Change from Baseline to Month 6 |
| Change in Waist/Hip Circumference | Change from Baseline to Month 12 |
| Change in Glucose | Change from Baseline to Month 6 |
| Change in Glucose | Change from Baseline to Month 12 |
| Change in Health Related Quality | 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 from Baseline to Month 6 |
| Change in Health Related Quality | 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 from Baseline to Month 12 |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |