P3BC for Bladder Cancer, Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Bladder Cancer, Cancer+1 More
P3BC - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a decision aid can help patients with bladder cancer make better decisions about their care.

See full description

Eligible Conditions

  • Bladder Cancer, Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Bladder Cancer, Cancer

Study Objectives

This trial is evaluating whether P3BC will improve 2 primary outcomes and 7 secondary outcomes in patients with Bladder Cancer, Cancer. Measurement will happen over the course of Baseline.

3 month
Brief Symptom Index (BSI-18)
Decisional Conflict Scale
Shared Decision Making Questionnaire (SDM-Q-9)
3 month followup
Acceptability E-scale
Program Evaluation Scale
3 months
Bladder Cancer Knowledge Scale
Self-Care Difficulty Scale
The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
Baseline
Control Preferences Scale (CPS)

Trial Safety

Safety Progress

1 of 3

Other trials for Bladder Cancer, Cancer

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Intervention (P3-BC) Usual Care
1 of 2
Active Control
Experimental Treatment

This trial requires 45 total participants across 2 different treatment groups

This trial involves 2 different treatments. P3BC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention (P3-BC) Usual Care
Behavioral
intervention + usual care group. In addition to receiving usual care, patients will have access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.
Usual Care

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 month for reporting.

Who is running the study

Principal Investigator
N. E. M.
Prof. Nihal E Mohamed, Associate Professor
Icahn School of Medicine at Mount Sinai

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pelvic exenteration for metastatic disease Some patients will require a cystectomy for their cancer show original
at least the age of 18 years; at least 18 years of age. show original
able to speak English; able to converse in English. show original
They are able to give consent. show original

Patient Q&A Section

Has p3bc proven to be more effective than a placebo?

"P3bc was found to be more effective than a placebo in terms of decreasing urinary urgency and urge incontinence. The improvement lasted for at least 6 months. Further studies should examine the effects of P3bc on symptoms associated with overactive bladder." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating urinary bladder cancer?

"The majority of urothelial carcinoma cases are diagnosed at an advanced stage when metastasis is already present. Therefore, it remains difficult to treat surgically. According to current research, the epigenetic regulation of oncogenes and tumor suppressor genes seems to be key for both the development and progression of urothelial carcinomas. Most cancers require more than one drug to achieve a cure, but this needs further investigations." - Anonymous Online Contributor

Unverified Answer

Can urinary bladder cancer be cured?

"There were no differences between the groups with respect to age, gender, tumor stage, or preoperative chemotherapy duration. The recurrence rates were statistically not different either (P = 0.4965). In addition, there was no difference in the recurrence rate between the groups with regard to the pathological type (squamous cell carcinoma vs transitional cell carcinoma) (P = 0.9477). Overall, the 5-year recurrence rate was 6.7% for surgically treated patients and 11.4% for treated patients without surgery. The 5-year recurrence rate was comparable between the groups with regard to the pathological type (P = 0.8451)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of urinary bladder cancer?

"In both males and females, smoking was associated with an increased risk of bladder cancer. Interestingly, the association between smoking and bladder cancer was stronger in women than in men. This finding may have important implications for prevention strategies, which should be tailored to gender." - Anonymous Online Contributor

Unverified Answer

How many people get urinary bladder cancer a year in the United States?

"The data suggest that the annual incidence of urinary bladder cancer among whites exceeds that for blacks by 2% to 3%. Observed heterogeneity suggests the existence of racial differences in the etiology of urinary bladder cancer." - Anonymous Online Contributor

Unverified Answer

How serious can urinary bladder cancer be?

"The U.S. Bureau of Health Statistics estimates that <10,000 people will die from [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) in 2007, making it the 16th-leading cause of death among men. Although the absolute risk associated with bladder cancer is low, the number of cases detected each year is still large enough to impair everyday life. Urinary bladder cancer is not one of the most common cancers, but it represents 8% of all cancers diagnosed in men and 6% of all cancers diagnosed in women. For those affected by urinary bladder cancer, current treatments do not always provide complete remission, which means [that even though the cancer has been eliminated, the disease may recur or spread to other parts of the body] (https://www.cdc." - Anonymous Online Contributor

Unverified Answer

How quickly does urinary bladder cancer spread?

"The usual course of disease is from the time when the patient first complains of abdominal discomfort or pain to detection of a malignant mass. Consequently, the diagnosis of bladder cancer takes longer than it would if the patient had a nonmalignant disorder." - Anonymous Online Contributor

Unverified Answer

What is the latest research for urinary bladder cancer?

"There were no significant differences between the two groups in terms of overall survival rate (p=0.903), radical resection rate (p=0.723), or recurrence rate (p=0.814). The only factor that showed statistically significant difference was pathological stage (p=0.029). Radical resection was significantly related to increased likelihood of recurrence (p=0.014)." - Anonymous Online Contributor

Unverified Answer

Does urinary bladder cancer run in families?

"Although there is considerable evidence of genetic predisposition for [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer), little is known about other cancers such as prostate or brain cancer. In this small series, no consistent pattern was found for either prostate or brain cancer in the family members of patients with bladder cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for urinary bladder cancer?

"The prognosis for bladder cancer has improved significantly over the past 30 years, possibly due to earlier detection and increased use of multimodality therapy. Although overall survival remains poor, patients with Stage III disease have strikingly different outcomes based on age at presentation and tumor grade." - Anonymous Online Contributor

Unverified Answer

What are common treatments for urinary bladder cancer?

"The treatments for superficial bladder cancer vary widely between countries. Physicians should be aware that there is no consensus regarding the best treatment. For those who choose surgery, they should be aware that surgical oncologists have differing opinions about surgical resection and radiation therapy. More research is needed to develop better guidelines for the treatment of superficial bladder cancers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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