Trial record 10 of 67 for:    Open Studies | "Sexual Dysfunction, Physiological"

Health Interventions in Men Undergoing Radical Prostatectomy (HIM-UP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01748110
First received: December 10, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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, 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, blood pressure, and metabolic parameters, including serum glucose and cholesterol levels, is expected.


Condition Intervention Phase
Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Urinary Incontinence
Quality of Life
Behavioral: Intensive Fitness Intervention
Behavioral: TRIMM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Expanded Prostate Cancer Index (EPIC)-26 [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
    This is a validated measure of quality of life after prostate cancer treatment.


Secondary Outcome Measures:
  • RAND-12 Questionnaire [ Time Frame: 3,6,12,18 months post-operatively ] [ Designated as safety issue: No ]
    this is an overall measure of quality of life

  • body weight change [ Time Frame: 3,6,12,18 months post-operatively ] [ Designated as safety issue: No ]
  • body mass index (BMI) change [ Time Frame: 3, 6, 12, 18 months post-operatively ] [ Designated as safety issue: No ]
  • blood pressure (BP) change [ Time Frame: 3, 6, 12, 18 months post-operatively ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) [ Time Frame: 3, 6, 12, 18 months post-operatively ] [ Designated as safety issue: No ]
    This is a validated measure of erectile function

  • Quality of Erection Questionnaire (QEQ) [ Time Frame: 3, 6, 12, 18 months post-operatively ] [ Designated as safety issue: No ]
    This is a validated measure of erectile rigidity


Estimated Enrollment: 125
Study Start Date: December 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: local patients
This arm is for local patients randomized to standard recommendations for fitness/health interventions prior to surgery (local control group)
Experimental: local patients-TRIMM
These local patients will be randomized to health interventions via receipt of text message reminders/prompts.
Behavioral: TRIMM
text message intervention.
Experimental: local patients-Intensive
This arm is for local patients who will be randomized to undergoing intensive fitness interventions according to the Look AHEAD model.
Behavioral: Intensive Fitness Intervention
This intervention will involve adhering to health interventions such as behavior and diet modification, and exercise. Patients will follow-up weekly with a health counselor to verify progress.
Other Name: Look AHEAD model
No Intervention: distant patients
This arm is for distant patients who will be randomized to standard fitness/health interventions (control group).
Experimental: Distant patients-TRIMM
This arm is for distant patients who will be randomized to receive text messages a their fitness intervention.
Behavioral: TRIMM
text message intervention.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men 40-65 years of age
  • localized prostate cancer (clinical stage < T2b, Gleason grade < 7, PSA (prostate specific antigen) < 10)
  • scheduled to undergo curative nerve-sparing prostatectomy at the Johns Hopkins Hospital

Exclusion Criteria:

  • in a stable relationship for < 6 months
  • moderately to severely impaired preoperative erectile function (IIEF-erectile function domain score < 16)
  • answering less than 2-3 times or > to question #6 on the IIEF
  • severe lower urinary tract symptoms (International Prostate Symptom Score) [IPSS] >20
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748110

Contacts
Contact: Arthur L Burnett, MD, MBA 410-614-3986 aburnet1@jhmi.edu
Contact: Robert L Segal, MD, FRCS(C) 410-614-0241 rsegal3@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Robert L Segal, MD, FRCS(C)    410-614-0241    rsegal3@jhmi.edu   
Contact: Lawrence J Cheskin, MD    410-502-0145    lcheskin@jhsph.edu   
Sub-Investigator: Robert L Segal, MD, FRCS(C)         
Sub-Investigator: Lawrence J Cheskin, MD         
Sub-Investigator: Joy U Blitz, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
  More Information

No publications provided

Responsible Party: Arthur L. Burnett, M.D., Patrick C. Walsh Professor of Urology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01748110     History of Changes
Other Study ID Numbers: NA_00070555
Study First Received: December 10, 2012
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Prostatic Neoplasms
Urinary Incontinence
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014