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Quality of life (QOL) of bladder cancer patient treated with surgery or radiotherapy.

Quality Of Life Measures after Bladder Preservation and Cystectomy: A prospective longitudinal comparative study - QOMPACT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/059560
Enrollment
250
Registered
2023-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C679- Malignant neoplasm of bladder, unspecified

Interventions

None listed

Sponsors

Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 18 years 2. Able to understand and sign the informed consent form in English, Hindi, or Marathi. 3. Able to understand and fill the QOL questionnaires in English, Hindi, or Marathi. 4. Patients with pathologically confirmed bladder cancer planned for curative intent treatment at TMC Mumbai. 5. AJCC Clinical Stage T1-T4, N0-N3, M0 6. Planned for treatment with either radical cystectomy with ileal conduit (RCIC) or radiotherapy with or without chemotherapy as a part of bladder preservation approach. 7. May or may not have received neoadjuvant chemotherapy with either approach

Exclusion criteria

Exclusion criteria: 1. Patients with a history of prior radiation to the pelvis 2. Patients in whom the cystectomy is planned as a salvage procedure 3. Patients who are planned for a neobladder after cystectomy 4. Patients who have any other active malignancy 5. Patients who are being considered for palliative or weekly radiotherapy 6. Patients who refuse to consent to the study

Design outcomes

Primary

MeasureTime frame
To compare Quality of Life between patients undergoing radical cystectomy (RCIC) or bladder preservation using the EORTC QLQ C 30 and BCI questionnaires.Timepoint: 5 Years

Secondary

MeasureTime frame
To prospectively evaluate the acute toxicity with the two treatments 2. To prospectively evaluate the late toxicity with the two treatments 3. To prospectively evaluate the disease related outcomes in the two cohortsTimepoint: 5 years

Countries

India

Contacts

Public ContactDr. Yash Waghmode

ACTREC, Tata Memorial Centre

vedangmurthy@actrec.gov.in02224177028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026