Energy Balance for Prostate Cancer Survivorship

Jill Hamilton-Reeves, PhD RD LD20 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Weight Loss ProgramOTHER

Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.

Standard of CareOTHER

Standard of Care for this patient population.

Eligibility

Sex: MALEMin age: 50 YearsMax age: 72 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Change in body weight during the post-surgical period

Time frame: Change from Surgery to Week 20

Secondary Outcomes

Changes in body weight during the pre-surgical weight-loss intervention

Time frame: 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.

Time frame: Change from Baseline to Week 8

Prostate cancer status

Evidence of recurrence of cancer

Time frame: 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.

Time frame: Change from Baseline to Week 20

Data from ClinicalTrials.gov

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