Health Interventions in Men Undergoing Radical Prostatectomy
NCT01748110 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2017-01-26
Summary
The goal of the study is to assess the impact of a health intervention, involving both diet and exercise modification, on outcomes following radical prostatectomy for the treatment of clinically localized prostate cancer. The specific urological outcomes expected to be improved are accelerated and/or improved recovery of erectile function (EF), as well as urinary continence, both very commonly affected by this surgery. Furthermore, as demonstrated by changes in responses to various questionnaires, an improvement in overall health-related quality of life is expected. Finally, an improvement in patients participating in the intervention groups in physical parameters, including body mass index (BMI), blood pressure (BP), and metabolic parameters, including serum glucose and cholesterol levels, is expected.
Conditions
- Prostate Cancer
- Erectile Dysfunction Following Radical Prostatectomy
- Urinary Incontinence
Interventions
- BEHAVIORAL
-
Intensive Fitness Intervention
This intervention will involve adhering to health interventions such as behavior and diet modification, and exercise. Patients will follow-up monthly with a health counselor to verify progress.
- BEHAVIORAL
-
TRIMM
text message intervention.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Arthur L Burnett, MD, MBA · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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