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Improving Continence and Quality of Life in Prostate Cancer Patients (StayDry)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Case Western Reserve University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01365182
First received: May 26, 2011
Last updated: June 1, 2011
Last verified: May 2011
History of Changes
  Purpose

This is a randomized, controlled longitudinal study of 312 early-stage prostate cancer patients that experience urinary incontinence six months after the completion of cancer treatment. This "STAY DRY" research program uses biofeedback to teach pelvic floor muscle exercises (PFME) and combines it with a telephone or support group intervention to treat persistent urinary incontinence. The study's primary aims are to improve continence, quality of life, and mood through enhancing adherence to PFME and self-management of bladder control. The secondary aims are to examine the physiological effects and cost effectiveness of the proposed interventions. The study hypothesizes that the proposed intervention will improve continence, quality of life and mood of prostate cancer patients and reduce the cost.


Condition Intervention Phase
Urinary Incontinence
Mood
 Behavioral: BF+GROUP; BF+PHONE
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Continence and Quality of Life in Prostate Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Urinary incontinence [ Time Frame: Change from baseline in urinary incontinence at 6 months ] [ Designated as safety issue: No ]
    Urinary incontinence is measured in the amount and frequency of urinary leakage

  • Quality of life [ Time Frame: Change from baseline in quality of life at 6 months ] [ Designated as safety issue: No ]
    Quality of life is measured by standard instrument (SF36 etc.) as an continuous variable

  • Mood [ Time Frame: Change from baseline in mood at 6 months ] [ Designated as safety issue: No ]
    Mood is measured by POMS as a continuous variable


Secondary Outcome Measures:
  • Physiological changes in muscle condition [ Time Frame: Change from baseline in physiological condition at 3 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: Change from baseline in the cost-effective ratio at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF+GROUP
BF+GROUP entails biofeedback-based pelvic floor muscle exercise plus behavioral intervention that is delivered through a support group
 Behavioral: BF+GROUP; BF+PHONE
biofeedback-based pelvic floor muscle exercise and behavioral interventions that teach self management skills through a support group or telephone contacts as described above
Active Comparator: BF+PHONE
BF+PHONE entails biofeedback-based pelvic floor muscle exercise plus behavioral intervention that is delivered through telephone contacts
 Behavioral: BF+GROUP; BF+PHONE
biofeedback-based pelvic floor muscle exercise and behavioral interventions that teach self management skills through a support group or telephone contacts as described above
No Intervention: UC
UC refers to the "usual care." This is an observational group without any intervention
 Behavioral: BF+GROUP; BF+PHONE
biofeedback-based pelvic floor muscle exercise and behavioral interventions that teach self management skills through a support group or telephone contacts as described above

Detailed Description:

Study participants will be randomly assigned to one of three study arms: (1) biofeedback PFME plus a support group (BF+GROUP); (2) biofeedback PFME plus telephone (BF+PHONE); and (3) usual care (UC). The BF+GROUP and BF+PHONE participants will learn PFME through computerized biofeedback. Thereafter, the BF+GROUP participants will attend six group meetings and the BF+PHONE participants will have six phone contacts every other week for three months. The interventions use a Problem-Solving Therapy (PST) framework to treat UI. The UC participants will not receive biofeedback PFME or telephone/group intervention but will continue receiving usual medical care. In addition, 51 moderately to severely incontinent patients will be recruited from the three study groups, with 17 per group, to undergo urodynamic testing at T1 and T2. Data of the costs for the interventions and the participants' medical care will be collected for a cost-effectiveness analysis.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. stage I, II and III prostate cancer;
  2. having completed treatment (surgery or radiation) at least six months prior;
  3. presence of UI symptoms.

Exclusion Criteria:

  1. receiving hormonal treatment
  2. urinary tract infection or urinary retention
  3. cognitive impairment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365182

Contacts
Contact: Amy Zhang, Ph.D. 2163680968 Amy.Zhang@case.edu
Contact: John O'Neill, BS 21636836342 john.f.oneill@case.edu

Locations
United States, Ohio
Case Comprehensive Cancer Center (UHCMC, CCF, MetroHealth) Recruiting
Cleveland, Ohio, United States, 44106
Contact: John O'Neill, BS     216-368-6342     john.f.oneill@case.edu    
Sponsors and Collaborators
Case Western Reserve University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Amy Zhang, Ph.D. Case Western Reserve University
  More Information

No publications provided

Responsible Party: Amy Y. Zhang, Ph.D., FPB School of Nursing, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01365182     History of Changes
Other Study ID Numbers: 1R01CA127493-01A2, 1R01CA127493-01A2
Study First Received: May 26, 2011
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
prostate cancer
urinary incontinence
pelvic floor muscle exercise
 self-management
behavioral intervention
quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013