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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
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The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight loss intervention Group | Experimental | Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience. |
|
| Comparison Group | Active Comparator | All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Program | Other | Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight during the post-surgical period | Change from Surgery to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight during the pre-surgical weight-loss intervention | Change from Baseline to Week 8 | |
| Changes in diet quality during the pre-surgical weight-loss intervention | Changes will be measured by analyzing results from alternative healthy eating index scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Hamilton-Reeves, PhD, RD, LD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33295204 | Derived | Hamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061217 | Weight Reduction Programs |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Standard of Care | Other | Standard of Care for this patient population. |
|
| Change from Baseline to Week 8 |
| Prostate cancer status | Evidence of recurrence of cancer | Week 20 |
| Change in cardiovascular biomarkers | Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose. | Change from Baseline to Week 20 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 |
| Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |