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

This study has been withdrawn prior to enrollment.
(Funding could not be secured)
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01748110
First received: December 10, 2012
Last updated: January 25, 2017
Last verified: January 2017
  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 (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.

Condition Intervention
Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy Urinary Incontinence Behavioral: Intensive Fitness Intervention Behavioral: TRIMM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
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:
  • Change in erectile function (EF) [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
    The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
    The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
    The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  • Change in EF [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
    The Quality of Erection (QEL) questionnaire will be administered. This is a 6 item questionnaire addressing the patient's perception of erectile rigidity during sexual activity. It is scored from 0-100 with 100 indicating the highest quality erection

  • Change in Urinary function [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
    The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  • Change in Urinary function [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
    The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  • Change in Urinary function [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
    The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction

  • change in urinary function [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
    The expanded prostate cancer index (EPIC-26) urinary domain will be administered. This is a 7 item questionnaire addressing the patient's perception of their urinary function over the previous 4 weeks. Higher scores indicate a greater degree of urinary dysfunction


Secondary Outcome Measures:
  • change in health related quality of life [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
    The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.

  • change in health related quality of life [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
    The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.

  • change in health related quality of life [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
    The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.

  • change in health related quality of life [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
    The RAND 12 questionnaire will be administered. This is a validated questionnaire evaluating the patient's perception of their overall health.

  • change in sexual satisfaction [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
    The EPIC-26 sexual domain questionnaire will be administered. This is a 9 item questionnaire used to evaluate the patient's perception of their sexual satisfaction over the previous 4 weeks. Higher scores indicate greater dissatisfaction and dysfunction

  • change in sexual satisfaction [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
    The EPIC-26 sexual domain questionnaire will be administered. This is a 9 item questionnaire used to evaluate the patient's perception of their sexual satisfaction over the previous 4 weeks. Higher scores indicate greater dissatisfaction and dysfunction

  • change in sexual satisfaction [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
    The EPIC-26 sexual domain questionnaire will be administered. This is a 9 item questionnaire used to evaluate the patient's perception of their sexual satisfaction over the previous 4 weeks. Higher scores indicate greater dissatisfaction and dysfunction

  • change in sexual satisfaction [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
    The EPIC-26 sexual domain questionnaire will be administered. This is a 9 item questionnaire used to evaluate the patient's perception of their sexual satisfaction over the previous 4 weeks. Higher scores indicate greater dissatisfaction and dysfunction

  • Change in Body mass index (BMI) [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
  • Change in Body mass index (BMI) [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
  • Change in Body mass index (BMI) [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
  • Change in Body mass index (BMI) [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
  • Change in serum cholesterol level [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
  • Change in serum cholesterol level [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
  • Change in serum cholesterol level [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
  • Change in serum cholesterol level [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
  • Change in blood pressure (BP) [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
  • Change in blood pressure (BP) [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
  • Change in blood pressure (BP) [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
  • Change in blood pressure (BP) [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]
  • Change in serum glucose [ Time Frame: From baseline (4 weeks before surgery) to 3 months after surgery ]
  • Change in serum glucose [ Time Frame: From baseline (4 weeks before surgery) to 6 months after surgery ]
  • Change in serum glucose [ Time Frame: From baseline (4 weeks before surgery) to 12 months after surgery ]
  • Change in serum glucose [ Time Frame: From baseline (4 weeks before surgery) to 18 months after surgery ]

Enrollment: 0
Study Start Date: December 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Local Control Group
This arm is for patients in the District of Columbia (DC), (Maryland) MD, (Virginia) VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to standard recommendations for fitness/health interventions prior to surgery.
Experimental: Local TRIMM Group
This arm is for patients in the DC, MD, VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to receive daily text message reminder and prompts targeted to the patient's dietary, fitness and urologic goals and needs using the Tailored Rapid Interactive Mobile Messaging (TRIMM) method. Patients will receive these text messages from 4 weeks prior to surgery until 8 week after surgery
Behavioral: TRIMM
text message intervention.
Other Name: Tailored Rapid Interactive Mobile Messaging
Experimental: Local Intensive Group
This arm is for patients in the DC, MD, VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to undergo intensive in-person fitness interventions according to the Look AHEAD model. This will involve attendance at weekly support group meetings and personal monthly meetings with a health care provider/
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.
Other Name: Look AHEAD model
No Intervention: Distant Control Group
This arm is for geographically distant patients that are unable to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to standard recommendations for fitness/health interventions prior to surgery.
Experimental: Distant TRIMM Group
This arm is for geographically distant patients that are unable to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to receive daily text message reminder and prompts targeted to the patient's dietary, fitness and urologic goals and needs using the Tailored Rapid Interactive Mobile Messaging (TRIMM) method. Patients will receive these text messages from 4 weeks prior to surgery until 8 week after surgery
Behavioral: TRIMM
text message intervention.
Other Name: Tailored Rapid Interactive Mobile Messaging

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes 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, pre-operative prostate specific antigen (PSA) < 10)
  • scheduled to undergo curative nerve-sparing prostatectomy at the Johns Hopkins Hospital

Exclusion Criteria:

  • in a stable relationship for at least 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

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01748110     History of Changes
Other Study ID Numbers: NA_00070555
Study First Received: December 10, 2012
Last Updated: January 25, 2017

Keywords provided by Johns Hopkins University:
quality of life
erectile function

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Erectile Dysfunction
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on June 22, 2017