Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Patients who underwent radical cystectomy for bladder cancer in our centre

All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...

Radical Cystectomy

Simone Morselli, MD

Silvia Benemei, PhD

Arcangelo Sebastianelli, MD

Sergio Serni, Prof

Mauro Gacci, MD

Maria Rosaria Raspollini, MD

Riccardo Campi, MD

Donata Villari, MD

Graziano Vignolini, MD

Saverio Giancane, MD

Pietro Spatafora, MD

Andrea Liaci, MD

Luca Gemma, MD

Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery

Robotic Radical Cystectomy Outcomes

Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy

Bladder Cancer Specific Mortality after surgery

Robotic surgery specific impact on survival

Robotic surgery specific impact on recurrence

Robotic surgery specific impact on surgical complications

Robotic surgery specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)

Urinary diversion specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)

Urinary diversion specific impact on surgical complications

Urinary diversion specific impact on bladder cancer recurrence

Urinary diversion specific impact on bladder cancer rmortality

Urinary diversion specific impact on all cause mortality after surgery

Azienda Ospedaliero-Universitaria Careggi

University of Florence

PhD Student

Bladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual.

Bladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus access to Internet based software program, specifically designed for this research study. Software program contains relevant bladder cancer care instructions through videos, text, and graphics.

Intervention support is patient initiated and accessed as needed

Cancer Resource Information Support (CRIS)

Usual care is enhanced with the addition of the NCI Facing Forward brochure

Usual Care Enhanced

Michael Diefenbach, PhD

Thomas Mistretta, MPH

Emmanuel Lapitan

Suzanne Miller, PhD

For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks during their recovery. To aid in recovery and enhance quality of life this program of research will develop and evaluate a multi-stage intervention geared towards patients and their caregivers. Part 1 of this program will have a nurse or trained health professional prepare both patients and their caregivers before treatment about the upcoming surgery. During this time the nurse will also demonstrate the necessary tools and techniques for stoma care. In addition, patients and their caregivers will receive access to a recovery website, specifically designed for bladder cancer patients to be used as a resource for after treatment. The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by other patients and physicians and a variety of other resources. Patients and caregivers in the control group will receive the Facing Forward brochures from the National Cancer Institute in part 2. This research has been funded by the National Cancer Institute and will be the first study to address the needs of bladder cancer patients and their caregivers. The ultimate goal of the study is to reduce infections and unplanned nurse/ER visits and improve quality of life for both patients and their caregivers. This new program will be evaluated over the course of 12-months and if found successful, has the potential to be disseminated throughout the health care systems of the two study sites.

Treatment for certain types of bladder cancer (BC) involves the removal of the bladder and construction of a new voiding system and is physically and psychologically profoundly challenging for patients and caregivers. Based on investigators' published literature and extensive pilot data, patients and caregivers have extensive unmet informational, social, psychological, instrumental, and medical needs from the time of diagnosis, through treatment and recovery which are not adequately addressed by health care professionals. Investigators propose to address these unmet needs through the refinement and evaluation of a comprehensive, 2-part (in-person and web-based) intervention, geared towards the patient and caregiver. Specifically, during Aim 1, the formative phase, investigators propose to further refine the newly developed intervention components with the help of an established patient/caregiver advisory board. The intervention, Recovery Support for Bladder Cancer (RSBC), consists of a pre-treatment, in-person preparatory instructional session with a trained health care professional (Module 1) to equip patients and caregivers with the skills to adjust to the upcoming treatment and recovery period. This is followed by a post-treatment, interactive web-based program (Module 2) to provide further support for both patients and caregivers to enhance quality of life (QOL) and reduce infections and nurse/ER visits. The RSBC intervention will be evaluated in a 12-month randomized controlled trial (Aim 2) among patients and caregiver dyads (N=287 initial; 238 final sample) against a time and attention comparison condition (the Facing Forward brochures). Primary outcomes for both patients and caregivers will be improved QOL, which is hypothesized to be significantly higher among participants randomized into RSBC. Secondary outcomes will be fewer infections and nurse-ER visits for patients randomized into RSBC. Aim 3 proposes moderator (i.e., age, gender, surgical diversion type) and mediator (i.e., patient activation, distress) analyses of intervention efficacy. Investigators hypothesize that RSBC will be significantly more successful among (a) older, (b) female participants, and (c) patients with a conduit diversion type. Elevated levels of patient activation (i.e., higher self-care knowledge, self-efficacy, lower distress) will mediate the intervention effects. Exploratory Aim 4 will examine the costs and potential savings associated with developing and implementing the RSBC intervention. Investigators hypothesize that initial development and implementation costs of RSBC will be offset by reduced nurse/ER visits. The scientific premise is strong and supported by an established theoretical framework, extensive pilot data and a rigorous application of clinical research methods. The proposed study is highly innovative, as it comprehensively addresses unmet needs of both patients and caregivers from pre- and (immediate) post-treatment to recovery. This is achieved through an innovative combination of in-person preparation and skill-building and web-based technology. If successful, RSBC has the potential to significantly change clinical care for patients and caregivers with BC.

The RSBC intervention will be evaluated in a 12-month randomized controlled trial among patients and caregiver dyads (N=287 initial; 238 final sample) against a time and attention comparison condition that focuses on general wellness.

Participants will be randomized based on a randomization table developed by study statistician. Care providers are not informed of the assigned study condition. Patients complete assessments through Redcap survey. Data analyst will be blinded to the nature of the numerical assignment of intervention vs control condition.

Recovery Support for Bladder Cancer Patients and Caregivers

Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach

Costs relative to the development, implementation \& maintenance of the intervention and cost of post-treatment care from the medical and billing records.

The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient

Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review

Fox Chase Cancer Center

Northwell Health

Professor, Director of Behavioral Research

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Nitrofurantoin

No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection

Prophylactic antibiotics postoperatively.

Prophylactic antibiotics postoperatively. All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days based on whether they had an ileal conduit or orthotopic neobladder, respectively, for the diversion. Participants will be instructed to swallow the capsule whole, preferably with food and at the same time each day. If a dose is forgotten, participants will be asked to take it when they remember and then take the next dose as usual. However, if they do not remember until the next dose, do not take extra capsules to make up the missed dose.

Maressa Twedt

Hamed Ahmadi

Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.

Prophylactic Antibiotics in Cystectomy With Diversion

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

Test for non-inferiority of no antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.

Difference in risk of UTI within the first 30 days postoperative between treatment and no treatment groups.

2-sample, 2-sided, t-test for a difference in proportions. Statistical hypothesis: H0: R1 - R2 = 0, Hα: R1 - R2 ≠ 0, where R1 is the risk (proportion) of UTI infection within the first 30 days, post operation, among those in the treatment group, and R2 among placebo.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Radical Cystectomy Outcomes	NCT04900558	Bladder Cancer Muscle-Invasive... Oncology Recurrence Surgery	Radical Cystect...	18 Years -	University of Florence
Robotic Radical Cystectomy Outcomes	NCT04900558	Bladder Cancer Muscle-Invasive... Oncology Recurrence Surgery	Radical Cystect...	18 Years -	University of Florence
Recovery Support for Bladder Cancer Patients and Caregivers	NCT04055311	Bladder Cancer Patient Engagem... Patient Empower... Ileal Conduit	Cancer Resource... Usual Care Enha...	18 Years -	Northwell Health
Prophylactic Antibiotics in Cystectomy With Diversion	NCT06190197	Muscle-Invasive... Radical Cystect... Ileal Conduit Neobladder Dive...	Prophylactic an...	18 Years -	University of Minnesota

Spots Global Cancer Trial Database for ileal conduit