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

ileal neobladder suspened with round ligament

Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer

rONB

ZhiWen Chen, M.D.

HuiXiang Ji, M.D.

Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

The investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. In this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.

Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study

number of patients with postvoiding residual urine (PVP) more than 100ml

number of patients required clean intermittent catheterization(CIC)

urodynamic parameter including peak flow rate, functional urethral length ...etc

number of patients with continence at daytime and nighttime

Zhiwen Chen

Vice director of urological institiute of PLA

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

Behaviors and Mental Disorders

Rare Diseases

Carcinoma, Transitional Cell

Disease Progression

Leiomyosarcoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Sarcoma

Quality of Life

Transitional Cell Carcinoma

Soft Tissue Sarcoma

A radical cystectomy is an operation to remove the whole bladder

Francesco Montorsi, MD

Giusy Burgio, MSc

Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

The data entered will concern:

* period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
* hospitalization period with all its related data
* questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

All patients, before underwent radical cystectomy, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history.

Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record.

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
Neobladder Posterior Wall Suspended With Round Ligament of Uterus	NCT01273987	Female Bladder Cancer Radical Cystect... Neobladder Posterior Wall ...	rONB	40 Years - 70 Years	Southwest Hospital, China
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
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy	NCT06170177	Muscle-Invasive... Muscle Invasive... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Leiomyo... Bladder Cancer Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Cancer ... Bladder Urothel... Progression, Di... Urinary Diversi... Neobladder Radical Cystect...	Radical Cystect...	18 Years -	IRCCS San Raffaele

Spots Global Cancer Trial Database for neobladder

Every month we try and update this database with for neobladder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for neobladder

Every month we try and update this database with for neobladder cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for neobladder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.