Prostate Cancer
Conditions
Keywords
prostate cancer, prostatectomy, weight loss, prevent weight gain
Brief summary
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.
Detailed description
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: 1. Diet 2. Physical activity 3. Coaching 4. Diet and exercise monitoring tool 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.
Interventions
OTHERWeight Loss Program
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
OTHERStandard of Care
Standard of Care for this patient population.
Sponsors
University of Kansas Medical Center
Jill Hamilton-Reeves, PhD RD LD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2) * Body Mass Index (BMI) 25-45 kg/m2 * Have internet access * Have an iPad/iPhone/iDevice
Exclusion criteria
* History of 5 alpha reductase inhibitors prior 3 months * History of radiation therapy * Taking active cancer treatment * Undergoing salvage therapy * Castration-resistant prostate cancer * Evidence of metastasis * Evidence of biochemical recurrence * High risk medical condition (e.g. gout or kidney disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight during the post-surgical period | Change from Surgery to Week 20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change from Baseline to Week 8 | Changes will be measured by analyzing results from alternative healthy eating index scores. |
| Prostate cancer status | Week 20 | Evidence of recurrence of cancer |
| Change in cardiovascular biomarkers | Change from Baseline to Week 20 | Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose. |
Countries
United States
Outcome results
None listed