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F1000Research

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F1000 Research Limited

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10.12688/f1000research.164225.2

Study Protocol

Articles

QUEST: Quality of Life and Evaluation of Survival in Treatment of Bladder Cancer – A Prospective Study on Quality of Life and Survival of Bladder Cancer Patients Using Patient-Reported Outcome Measurements (PROMs)

[version 2; peer review: 1 approved]

Chakrabarti

Jayanta

Conceptualization Data Curation Formal Analysis Funding Acquisition Investigation Methodology Project Administration Resources Software Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing 1 Ghosh

Debjit

Conceptualization Data Curation Formal Analysis Investigation Methodology Project Administration Software Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing https://orcid.org/0000-0002-9877-640X a 2 Ghosh

Ranti

Conceptualization Data Curation Investigation Methodology Project Administration Resources Validation Visualization Writing – Review & Editing 2 Lahiri

Debarshi

Data Curation Formal Analysis Funding Acquisition Methodology Project Administration Resources Supervision Validation Writing – Original Draft Preparation Writing – Review & Editing 2 Maji

Tapas

Funding Acquisition Investigation Project Administration Supervision Validation Visualization 2 Sen

Kushal

Data Curation Formal Analysis Investigation Methodology Resources Software Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing 2 Chakraborty

Debanjan

Data Curation Investigation Methodology Resources Software Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing 2 Priyaranjan

Tapas

Data Curation Investigation Supervision Visualization Writing – Original Draft Preparation Writing – Review & Editing 2 Saha

Chirantan

Investigation Resources Software Supervision Validation Writing – Original Draft Preparation Writing – Review & Editing 2 Bhattacharjee

Arit

Data Curation Investigation 2 Das

Sagnik

Data Curation Supervision Validation Visualization Writing – Original Draft Preparation Writing – Review & Editing 2 Mallick

Sukalita

Data Curation Investigation Methodology Resources Software Visualization Writing – Original Draft Preparation Writing – Review & Editing 2 1Department of Surgical Oncology, Chittaranjan National Cancer Institute, Kolkata, Kolkata, West Bengal, 700026, India 2Department of Radiation Oncology, Chittaranjan National Cancer Institute, Kolkata, Kolkata, West Bengal, 700026, India

a debjitghosh15@gmail.com

No competing interests were disclosed.

18 9 2025

2025

841

16 9 2025

2025

This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background

Muscle-invasive bladder cancer (MIBC) is a clinically aggressive disease requiring intensive treatment. The two principal curative approaches are radical cystectomy (RC) and bladder preservation therapy, most commonly trimodal therapy (TMT), which combines maximal transurethral resection of the bladder tumor (TURBT) with concurrent chemoradiation. While both strategies have demonstrated comparable oncologic outcomes in select patient populations, their impact on health-related quality of life (QoL) remains a crucial differentiator—particularly in real-world, resource-constrained settings where cultural and logistical considerations shape patient preferences and treatment access.

Objectives

The QUEST (Quality of life and Evaluation of Survival in Treatment of bladder cancer) study aims to evaluate and compare QoL outcomes and survival metrics in MIBC patients undergoing either RC or bladder preservation. It seeks to generate institution-specific data using validated patient-reported outcome measures (PROMs), thereby supporting individualized, evidence-informed decision-making.

Methods

This prospective, single-center, observational cohort study will enroll 94 patients with non-metastatic MIBC (cT2–T4aN0M0) who are eligible for either treatment approach. Participants will self-select their treatment modality following multidisciplinary counselling. QoL will be assessed longitudinally using the Bladder Cancer Index (BCI) and EORTC QLQ-C30 at baseline and multiple post-treatment intervals. Secondary endpoints include overall survival (OS), progression-free survival (PFS), and correlation of PROM scores with survival. Stratification and statistical adjustments will address inherent selection bias.

Discussion

The QUEST study will provide critical insights into the lived experiences and clinical outcomes of MIBC patients in eastern India. By integrating PROMs into routine oncologic evaluation, it will help bridge the gap between survival-centric and patient-centric care models. The findings are expected to inform future guidelines, promote shared decision-making, and enhance long-term care strategies for bladder cancer in similar healthcare settings.

Trial Registration: CTRI/2025/03/083504

Bladder cancer Muscle-invasive bladder cancer Quality of life Bladder preservation Radical cystectomy Patient-reported outcome measures

The author(s) declared that no grants were involved in supporting this work.

Revised Amendments from Version 1

The following changes have been made and mentioned in comments in the uploaded edited version. 1. Corrected spelling of “counselling” from “counselling”. 2. Added chemotherapy and radiotherapy regimen in bladder preservation arm, as per suggestion of 1 ^st reviewer. 3. Added neoadjuvant chemotherapy regimen in Radical Cystectomy arm, as per suggestion of 1 ^st reviewer. 4. PRO recording methods already described in the primary manuscript. Hence, no changes were made. 5. PRO and survival correlation already described in the primary manuscript. Hence, no changes were made. 6. Statistical software information added, as per suggestion of 1 ^st reviewer.

Background

Bladder cancer is one of the most prevalent genitourinary malignancies globally, with MIBC accounting for approximately 25-30% of newly diagnosed cases. ¹ MIBC, defined as clinical stage cT2-T4a, necessitates aggressive treatment to achieve oncological control while striving to maintain patients’ quality of life (QoL). ² Historically, radical cystectomy (RC) combined with neoadjuvant chemotherapy has been the standard of care, offering 5-year survival rates of approximately 50-60%. ³ RC entails complete bladder removal, pelvic lymphadenectomy, and urinary diversion, often resulting in significant QoL impairments across urinary, bowel, and sexual domains due to the creation of an ileal conduit or neobladder. ⁴ In recent decades, bladder preservation strategies, particularly trimodal therapy (TMT)—comprising maximal transurethral resection of bladder tumor (TURBT) followed by concurrent chemoradiotherapy—have gained traction as an alternative, with studies reporting comparable survival outcomes to RC in well-selected patients. ^{5,
6}

Randomized controlled trials (RCTs) directly comparing RC and TMT are limited, but observational studies and meta-analyses suggest that TMT achieves equivalent oncological efficacy for appropriately selected patients, with 5-year overall survival rates ranging from 50-70%. ^{7,
8} The potential QoL advantages of TMT, primarily due to retention of the native bladder, have been highlighted in studies using validated Patient-Reported Outcome Measures (PROMs) like the Bladder Cancer Index (BCI) and EORTC QLQ-C30, which demonstrate better urinary and sexual function compared to RC. ^{9,
10} However, TMT is not without drawbacks, as long-term radiation toxicities may affect bowel and bladder function. ¹¹

Despite these insights, most QoL data originate from Western populations, which may not fully reflect the experiences of patients in resource-constrained settings like India, where socioeconomic, cultural, and logistical factors influence treatment decisions. ¹² At our tertiary cancer center in eastern India, we manage a high volume of MIBC patients annually, yet institution-specific data comparing RC and TMT outcomes are lacking. The QUEST study aims to address this gap by prospectively evaluating QoL and survival in our patient population, contributing to tailored treatment decision-making.

Study design and objectives

The QUEST study, titled “QUality of Life and Evaluation of Survival in Treatment of Bladder Cancer,” is a prospective observational cohort study with the primary objective of comparing QoL outcomes between bladder preservation and RC using validated PROMs, specifically the BCI and EORTC QLQ-C30. Secondary objectives include evaluating overall survival (OS) and progression-free survival (PFS), as well as exploring correlations between QoL scores and survival outcomes. The workflow of the study is illustrated in the CONSORT diagram in Figure 1.

Table 1. Pre-treatment workup for candidates choosing Bladder Preservation (BP) approach.

Pertinent history	Prior pelvic irradiation (strict contraindication)
Physical examination	Any skeletal deformity or incapacity precluding ability to lie supine for a considerable amount of time for radiotherapy
Renal function	Creatinine, eGFR
Bladder function	Voiding history ± urodynamics
General fitness	ECOG PS
Chemo eligibility	Cisplatin eligibility workup, cardiac, audiometry
Infection status	Urine culture

The observational design reflects real-world treatment allocation, with patients selecting their treatment after receiving comprehensive information on the benefits and risks of each option. This approach aligns with clinical practice but introduces potential selection bias, which will be addressed through statistical adjustments.

Participant criteria and setting

The study is conducted at Chittaranjan National Cancer Institute, Kolkata, a high-volume tertiary care cancer center in Eastern India, serving a diverse population from urban and rural areas. Inclusion criteria include: •

Diagnosis of MIBC (cT2-T4aN0M0).

•

Eligibility for both bladder preservation and RC.

•

Age 18 years or older.

•

Willingness to provide informed consent.

Exclusion criteria are: •

Presence of metastatic disease (M1).

•

Prior pelvic irradiation or surgery affecting urinary or bowel function.

•

Unwillingness to complete PROM questionnaires.

These criteria ensure a focused cohort suitable for both treatments, reducing confounding from advanced disease or prior interventions.

Interventions

Patients are divided into two groups: •

Bladder Preservation Group (BP/TMT): Undergoes maximal TURBT followed by concurrent chemoradiotherapy (CRT), adhering to standard institutional bladder preservation protocols; which includes once weekly Cisplatin 40 mg/m ² with once daily radiotherapy fraction. The total radiotherapy dose imparted to the whole bladder with regional lymph nodes is 44 Gy followed by a 20 Gy boost to the gross tumour with adequate margins using daily image guidance with Volumetric Modulated Arc Therapy (VMAT).

•

Radical Cystectomy Group (RC): Receives neoadjuvant chemotherapy (3 weekly Gemcitabine 1000 mg/m ² intravenously on Day 1 and Day 8 + Cisplatin 70 mg/m ² intravenously on D1) followed by RC, with or without adjuvant therapy, consistent with current guidelines.

While specific chemotherapy regimens and radiation doses are not detailed, they align with institutional standards to maintain consistency with routine clinical practice.

Outcomes and assessment schedule

Primary Outcome: QoL is assessed using: •

Bladder Cancer Index (BCI): A disease-specific tool measuring urinary, bowel, and sexual function and bother, scored on a 0-100 scale, with higher scores indicating better QoL. ⁴

•

EORTC QLQ-C30: A general cancer-specific tool evaluating functional domains (physical, role, emotional, cognitive, social), symptom scales, and global health status, also scored on a 0-100 scale.

Secondary Outcomes: •

Overall survival (OS): Time from treatment initiation to death from any cause.

•

Progression-free survival (PFS): Time from treatment initiation to disease progression or death.

•

Correlation between QoL scores and survival outcomes.

Assessment schedule

•

Baseline: All decisions regarding preferred treatment of the patient and patient’s denial or consent for said treatment shall be taken in the presence of a multidisciplinary tumour board. All patients shall undergo standard diagnostic and staging procedures as per established guidelines.

Prior to treatment initiation: for demographic and disease characteristics, pre-existing co-morbidities and associated health issues.

For RC candidates: Pre-anesthetic (PAC) workup shall be the primary cornerstone of assessment for candidates consenting for radical cystectomy and shall start even before initiation of of neoadjuvant chemotherapy. The reason being, consenting RC candidates failing PAC workup are deemed medically inoperable and hence, shall be shifted to BP arm with informed written consent. Initiating PAC before chemotherapy saves upfront medically inoperable patients from unwanted exposure to cytotoxic chemotherapy.

For BP candidates: Pre-treatment workup shall include components elucidated in Table 1.

Follow-up: 1 month after treatment completion (Treatment completion = Date of discharge for RC patients OR Date of radiotherapy completion for BP patients), 3 months, 6 months, 9 months, 12 months, and annually thereafter, enabling longitudinal data collection.

Patients who undergo radical cystectomy would undergo regular clinical evaluations, imaging (such as CT or MRI of the abdomen and pelvis), chest imaging, and monitoring of renal function every 3–6 months for the first 2 years, then at increasing intervals. In addition, those with urinary diversions would be monitored for metabolic complications and stoma or pouch-related issues. For patients treated with bladder preservation by chemoradiation, follow-up would include cystoscopic evaluation with urine cytology and bladder biopsies at regular intervals (typically every 3 months for the first 2 years, then every 6 months until 5 years, and annually thereafter), along with periodic imaging of the upper urinary tract to detect local or distant recurrence. Lifelong surveillance shall be necessary in both groups due to the risk of late recurrences and long-term sequelae of treatment.

Sample size calculation

The design is of a prospective trial comparing quality of life (QoL) outcomes in muscle-invasive bladder cancer (MIBC) patients undergoing: Bladder preservation (BP) with chemoradiotherapy vs. Radical cystectomy (RC); with the primary endpoint being superiority in the QoL domain of patients opting for bladder preservation.

As per findings from Murthy et al., ⁷

In the sexual bother domain of the BCI, which was found to be significantly superior for BP arm, compared to RC arm:

BP mean score = 81

RC mean score = 62

Mean difference = 19 points; p = 0.02, indicating statistical significance

Standard deviations (SD): BP = 24.8; RC = 36.6

Effect size (Δ): 19 (mean difference in sexual bother score)

Pooled SD (σ): σ = √ { ( SD RC 2 + SD BP 2 ) / 2 } = √ { ( 36.6 2 + 24.8 2 ) / 2 } = 31.27

α (Type I error) = 0.05

Power (1 - β) = 0.80

Sample size formula (for equal group sizes): n = [{2*(Z _α/2+Z _β) ²}*σ ²]/Δ ²; Z _α/2 = critical value for a two-sided test at significance level α; Z _β = critical value corresponding to the power of the test (1 - β), i.e. 0.20. n = [ { 2 ∗ ( 1.96 + 0.84 ) 2 ∗ 31.27 2 } / 19 2 ] = 42.5 ≈ 43 patients

Accounting for approximately 10% attrition, sample size comes to 47 patients in each arm. Hence, a total 94 patients need to be recruited; 47 patients in each arm.

Figure 1. CONSORT (Consolidated Standards of Reporting Trials) diagram depicting workflow of the study. Statistical analysis

Baseline characteristics will be summarized with descriptive statistics (mean ± SD for continuous variables, frequencies for categorical variables). QoL scores will be compared between groups at each time point using t-tests or Mann-Whitney U tests, based on data distribution. Longitudinal changes within groups will be evaluated with paired t-tests or Wilcoxon signed-rank tests.

Survival outcomes (OS and PFS) will be analyzed using Kaplan-Meier curves, with group differences assessed via log-rank tests. Cox proportional hazards regression will examine treatment-survival associations, adjusting for confounders such as age, sex, comorbidity, and disease stage. Correlations between QoL and survival will be explored using Spearman’s rank correlation or similar methods.

Given the observational design, baseline differences may occur. Multivariable regression and sensitivity analyses, such as propensity score matching, will address potential selection bias. ¹³

All the mentioned statistical tests shall be carried out via proprietary IBM SPSS version 25 software.

Ethical considerations and timeline

The study protocol was approved by the Institutional Ethics Committee of Chittaranjan National Cancer Institute (CNCI-IEC-JC-2025-03), Kolkata, India. The study will be conducted in accordance with the ethical principles of the World Medical Association Declaration of Helsinki. ¹⁴ Written informed consent will be obtained from all participants before enrollment, and patient data will be anonymized and securely stored. The patient-reported outcome measures have been translated into local vernacular languages and culturally validated, with permissions obtained from the developers (e.g., University of Michigan for the BCI; EORTC for the QLQ-C30). The study is registered in the Clinical Trials Registry of India (CTRI/2025/03/083504). The timeline is elucidated in Table 2.

Table 2. Estimated timeline of the study.

IEC approval and setup	2 months (completed)
Recruitment	12 months
Follow-up and data collection	12 months
Analysis and manuscript preparation	6 months
Total duration	Approximately 3 years

Discussion

The QUEST study is designed to address an essential knowledge gap regarding the comparative quality of life (QoL) and survival outcomes between bladder preservation (BP) and radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC) within the Indian context. This is particularly important given the significant cultural, economic, and systemic differences that influence patient care in low- and middle-income countries (LMICs).

Our study builds upon and aims to enhance insights from prior prospective evaluations, notably the recently published BMJ Oncology study by Murthy et al., ⁷ which compared QoL in 104 Indian patients undergoing either RC with ileal conduit or BP with radiotherapy. While that study found better outcomes in sexual domains with BP, it reported no significant differences in urinary, bowel, or global health-related QoL. These findings, although valuable, are limited by several methodological caveats that QUEST seeks to address.

Firstly, the cross-sectional design of Murthy et al.’s study inherently restricts temporal understanding of QoL evolution post-treatment. In contrast, QUEST employs a prospective, longitudinal design, allowing for the assessment of QoL trajectories over time—a more robust approach given the dynamic nature of recovery and adaptation.

Secondly, while the BMJ study reported comparable urinary and bowel outcomes, the potential for response shift bias (i.e., patients recalibrating their internal QoL standards over time) was not formally accounted for. Moreover, non-responder bias, especially in the sexual domain (response rate: 53%), likely affected the accuracy of findings, as patients with worse outcomes may have opted out of sensitive questionnaires. QUEST aims to mitigate this through repeated PROM administration, greater cultural sensitization, and patient counselling to encourage honest and complete reporting.

Another key limitation of the Murthy study was heterogeneity in follow-up durations (median 31 months for RC vs. 18 months for BP), which introduces bias in QoL interpretation due to differential late toxicities or psychological adaptation. Our study enforces a uniform minimum 36-month follow-up, ensuring comparability across arms.

Additionally, the Murthy study excluded neo-bladder reconstructions—an increasingly relevant option with better cosmetic and continence outcomes than ileal conduits. In contrast, QUEST includes all RC modalities and stratifies analysis accordingly, offering a broader generalizability.

In summary, while previous evidence—including that from Murthy et al.—supports bladder preservation as a viable alternative to RC in terms of QoL and survival, their findings should be interpreted cautiously due to design limitations. The QUEST study is poised to provide complementary and enhanced insights through rigorous methodology, extended follow-up, and nuanced interpretation tailored to real-world Indian patients. These results are expected to inform not only clinical practice but also shared decision-making, patient counselling, and potentially, policy guidelines for MIBC management in LMICs. The use of validated PROMs ensures robust QoL assessment, ⁴ while the longitudinal follow-up strengthens survival analyses. ¹⁵

Limitations include potential selection bias due to non-randomization, which will be mitigated through statistical adjustments. ¹⁶ Results are expected to inform personalized treatment strategies and enhance patient counseling, contributing to the growing body of evidence supporting tailored approaches in MIBC management.

Ultimately, the results of QUEST will inform shared decision-making between patients and clinicians. Understanding the trade-offs in QoL and survival associated with each treatment modality in our local context is critical for personalized care. We anticipate that publishing this protocol and its extended data (SPIRIT checklist, consent materials) under open licenses will promote transparency and facilitate future research collaborations. The use of a CC0 license on Zenodo ensures that the protocol and related documents are immediately available for reuse by other researchers.

Conclusion

The QUEST study will generate institution-specific data on the comparative effectiveness of bladder preservation and RC for MIBC, focusing on QoL and survival. By addressing the unique needs of Indian patients, it aims to support shared decision-making and potentially influence clinical practice guidelines in similar settings. These findings may pave the way for future research to refine treatment protocols and optimize patient-centered outcomes in bladder cancer care.

Ethical considerations and timeline

Data availability Underlying data

No data associated with this article.

Extended data

Zenodo: Research Proposal for “QUEST: Quality of Life and Evaluation of Survival in Treatment of Bladder Cancer – A Prospective Study on Quality of Life and Survival of Bladder Cancer Patients Using Patient-Reported Outcome Measurements (PROMs)”, https://doi.org/10.5281/zenodo.15397535. ¹⁷

This project contains the following underlying data: •

SPIRIT Checklist.pdf

•

BCI Bengali translation.pdf

•

BCI Hindi translation.pdf

•

BCI_Original Questionnaire.pdf

•

Creative Commons Innovation PARTNERSHIP.pdf

•

CTRI Registration.pdf

•

IEC approval.pdf

•

INFORMED CONSENT FORM (ICF).pdf

•

Patient information sheet and choice.pdf

•

QLQ-C30 Bengali.pdf

•

QLQ-C30 Hindi.pdf

•

Request to use translations of Bladder Cancer Index (BCI) in Indian languages Hindi & Bengali for conducting a scientific research.pdf

•

Specimen-QLQ-C30-English.pdf

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

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Reviewer response for version 1

Roy

Somnath

1 Referee https://orcid.org/0000-0003-0099-1476 1Tata Medical Center, Rajarhat, India

Competing interests: No competing interests were disclosed.

15 9 2025

2025

This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

recommendation

approve

I reviewed the project. It looks nice. I have few suggestions. Please mention chemotherapy regimen in neoadjuvant and concurrent setting and mention dose of radiation will be given in CTRT arm. How patient reported outcome will be captured (paper or electronic device or any functional tools like that) needs to be mentioned and how it will be co-related with survival outcome. Mention histological subtype of MIBC into inclusion criteria. Mention statistical software for data analysis.

Is the study design appropriate for the research question?

Yes

Is the rationale for, and objectives of, the study clearly described?

Yes

Are sufficient details of the methods provided to allow replication by others?

Yes

Are the datasets clearly presented in a useable and accessible format?

Yes

Reviewer Expertise:

Lung cance, Breast cancer, Precision oncology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.