Quality of Life and Evaluation of Survival in Treatment of Bladder Cancer

QUEST: Quality of Life and Evaluation of Survival in Treatment of Bladder Cancer

A Prospective Study on QoL and Survival of Bladder Cancer Patients Using Patient-Reported Outcome Measurements PROMs

Principal Investigator Dr. Jayanta Chakrabarti

Co-Investigators Dr. Ranti Ghosh, Dr. Debarshi Lahiri, Dr. Tapas Maji, Dr. Debjit Ghosh

Background and Rationale

Bladder cancer is one of the most common malignancies worldwide, with muscle-invasive bladder cancer MIBC constituting approximately 25 to 30 percent of newly diagnosed cases. MIBC stage T2-T4a poses a significant clinical challenge, as it requires multimodal treatment strategies to achieve optimal oncological control and maintain quality of life QoL.

Evolution of MIBC Management

Historically, neoadjuvant chemotherapy followed by radical cystectomy RC emerged as the cornerstone of curative treatment for MIBC. Introduced in the early 20th century, radical cystectomy involves removal of the bladder, surrounding organs, and lymph nodes, often accompanied by urinary diversion procedures such as ileal conduit, continent cutaneous diversion, or neobladder reconstruction. While RC provides effective local control and long-term survival, it is associated with significant perioperative morbidity, impact on urinary and sexual function, and deterioration in overall QoL.

Over the past few decades, there has been a paradigm shift towards bladder preservation strategies, driven by advancements in multidisciplinary oncology care. Bladder preservation typically involves trimodal therapy TMT, which combines

1. Maximal transurethral resection of bladder tumor TURBT
2. Concurrent chemoradiotherapy CRT
3. Meticulous surveillance to detect recurrence or progression

This approach gained traction following landmark studies demonstrating comparable oncological outcomes between bladder preservation and radical cystectomy in well-selected patients. The development of modern radiotherapy techniques, such as image-guided radiotherapy IGRT and intensity-modulated radiotherapy IMRT, has further improved tumor control while minimizing radiation toxicity to adjacent normal tissues. Concurrently, systemic therapies such as gemcitabine-based or cisplatin-based chemotherapy regimens have enhanced the radiosensitizing effects, improving the efficacy of bladder preservation approaches.

Bladder Preservation versus Radical Cystectomy The QoL Perspective

While survival and disease progression outcomes for TMT and RC are now considered equivalent in selected patients, their impact on QoL is markedly different. Radical cystectomy, despite being curative, often leads to profound changes in urinary, bowel, and sexual function due to the absence of the native bladder and the need for urinary diversion. Conversely, bladder preservation aims to maintain the natural bladder, thereby preserving functional outcomes and improving QoL for many patients.

Several studies, including an Indian study, have compared QoL between the two modalities using validated Patient-Reported Outcome Measures PROMs such as the Bladder Cancer Index BCI and the EORTC QLQ-C30. These studies consistently demonstrate that bladder preservation offers superior QoL, particularly in the domains of urinary function, bowel function, and sexual health. However, such data remain limited in the Indian context, where treatment decisions are influenced by socioeconomic, cultural, and logistical factors.

Need for the Current Study

Given the rising burden of bladder cancer and the increasing adoption of bladder preservation strategies, there is a need for institution-specific data to guide clinical decision-making. At our tertiary care cancer center in eastern India, we manage a substantial number of MIBC patients annually. While previous studies have provided valuable insights into QoL outcomes, there is limited evidence integrating QoL metrics with survival outcomes in a prospective cohort.

Given the large volume of bladder cancer patients treated annually at our center, there is a unique opportunity to replicate this study while also integrating survival outcomes with patient-reported QoL metrics. This will help establish institution-specific data to guide treatment planning and shared decision-making tailored to our patient population.

Objectives

Primary Objective

To compare quality of life QoL outcomes between bladder preservation and radical cystectomy patients using validated PROM tools

• Bladder Cancer Index BCI
• EORTC QLQ-C30

Secondary Objectives

1. To assess overall survival OS and progression-free survival PFS of patients undergoing bladder preservation versus radical cystectomy
2. To correlate PROM-derived QoL scores with survival outcomes

Methods

Study Design

A prospective observational cohort study.

Study Population

Inclusion Criteria

1. Patients diagnosed with muscle-invasive bladder cancer MIBC, cT2-T4aN0M0
2. Patients eligible for both bladder preservation and radical cystectomy
3. Age 18 years or older
4. Informed consent to participate

Exclusion Criteria

1. Patients with metastatic disease M1 at presentation
2. Prior pelvic irradiation or surgery affecting urinary or bowel function
3. Patients unwilling to complete PROM questionnaires

Sample Size

Based on the institutional annual caseload of bladder cancer and the expected response rates for PROMs, a total of n patients will be recruited over a 12-month enrollment period.

Study Groups

Patients will be stratified into two groups based on their treatment choice guided by informed consent forms in their mother tongue, explaining the pros and cons of each choice of modality

• Group 1 Bladder preservation TURBT plus chemoradiation
• Group 2 Neoadjuvant chemotherapy followed by radical cystectomy with or without adjuvant therapy

Study Tools

1. Bladder Cancer Index BCI A validated PROM tool measuring urinary, bowel, and sexual QoL domains
2. EORTC QLQ-C30 A global cancer QoL tool assessing functional, symptom, and global health status scales

Note The institution has secured the license to use BCI from the University of Michigan. Translations into local vernacular languages will be validated prior to use.

Data Collection

Baseline Assessment Demographic data, clinical staging, comorbidities, and baseline PROM questionnaires.

Follow-Up Intervals PROM assessments will be performed at 3 months 6 months 12 months Thereafter annually

Survival Data Overall survival and progression-free survival will be monitored at regular clinical follow-ups.

Statistical Analysis

• Descriptive Statistics Mean, median, and standard deviation for QoL scores
• Inferential Statistics Comparison of QoL between groups using t-tests or Mann-Whitney U tests. Kaplan-Meier curves for OS and PFS analysis. Cox proportional hazards regression to evaluate the correlation between QoL scores and survival outcomes
• Software IBM SPSS version 25

Ethical Considerations

1. Ethics Approval The study will be submitted for approval to the Institutional Ethics Committee IEC
2. Informed Consent Written informed consent will be obtained from all participants after providing detailed information about the study
3. Confidentiality Patient data will be anonymized and stored securely in password-protected systems
4. PROM Tools Local vernacular translations will be validated as per standard protocols to ensure cultural appropriateness and linguistic accuracy

Timeline

Phase	Duration
IEC Approval and Study Setup2 months
Participant Recruitment12 months
Follow-up and Data Collection12 months
Data Analysis and Manuscript6 months

Total Study Duration Approximately 3 years

Expected Outcomes

• A comprehensive comparison of QoL outcomes between bladder preservation and radical cystectomy in our patient population
• Institution-specific survival data correlated with PROM-derived QoL scores
• Insights to inform patient counseling, shared decision-making, and treatment planning