Energy Balance for Prostate Cancer Survivorship

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weight loss intervention Group

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.

Group Type EXPERIMENTAL

Weight Loss Program

Intervention Type 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.

Comparison Group

All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of Care for this patient population.

Interventions

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Weight 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.

Intervention Type OTHER

Standard of Care

Standard of Care for this patient population.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

72 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No