Health Interventions in Men Undergoing Radical Prostatectomy (HIM-UP)
This study is currently recruiting participants.
Verified December 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01748110
First received: December 10, 2012
Last updated: December 27, 2012
Last verified: December 2012
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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 < 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
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: | December 27, 2012 |
| 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 May 19, 2013