|Grant Number:||1R01CA127493-01A2 Interpret this number|
|Primary Investigator:||Zhang, Amy|
|Organization:||Case Western Reserve University|
|Project Title:||Improving Urinary Continence and Quality of Life in Prostate Cancer Patients|
DESCRIPTION (provided by applicant): The National Cancer Institute set the Challenge Goal of eliminating cancer suffering and death by 2015. Improving cancer care and the quality of life for cancer survivors is a critical component of this mission. Despite a 93% rate of 10-year survival in patients with prostate cancer - the most common cancer diagnosis in men - incidence of urinary incontinence (UI) resulting from radical prostatectomy is reported to be as high as 87%. Thirty percent of prostate cancer patients remain incontinent one year after surgery, and according to the NCI-funded Prostate Outcome Study, 14% continue to leak five years later. Although evidence suggests that pelvic floor muscle exercises (PFME), combined with biofeedback training, significantly improves continence in the early months after prostatectomy, its effect on UI that persists for more than six months is inconclusive. Based on promising results from our pilot studies, we propose a "STAY DRY" intervention program that innovatively combines biofeedback PFME with a telephone or support group intervention to treat persistent UI. 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. This is a randomized, controlled longitudinal study. Three hundreds and twelve patients with early-stage prostate cancer and UI for more than six months 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. All participants will be assessed at baseline (T1), three months (T2), and six months (T3). Assessments will focus on (1) the study outcomes (UI, quality of life, and mood); (2) the intermediate outcomes (adherence to PFME and self-management); (3) the effect of mediating variables; (4) physiological outcomes; (5) cost-effectiveness; and (6) covariates that include demographic, socioeconomic, and medical variables. Urodynamic testing will provide preliminary physiological evidence of the intervention effect. A cost-effectiveness analysis will inform societal benefits over intervention costs. Overall, the study will contribute to the formulation of an effective solution to persistent UI and has the potential to change standard care and improve long-term follow-up care for prostate cancer survivors. PUBLIC HEALTH RELEVANCE: Despite a prevalence of urinary incontinence among post treatment prostate cancer patients, men who suffer from urinary incontinence and its embarrassing symptoms, i.e., involuntary urinary leakage, have few options to combat this debilitating problem. But that may soon change. A research team at Case Western Reserve University is proposing a study that uses computer-assisted biofeedback along with group and telephone-based therapy to hone preexisting techniques - the Kegel exercises - to bring relief to men suffering from urinary incontinence, ultimately helping them, as the title of the study program says, "STAY DRY."