Quality of life (QOL) of bladder cancer patient treated with surgery or radiotherapy.
- Conditions
- Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
- Registration Number
- CTRI/2023/11/059560
- Lead Sponsor
- Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Quality of Life between patients undergoing radical cystectomy (RCIC) or <br/ ><br>bladder preservation using the EORTC QLQ C 30 and BCI questionnaires.Timepoint: 5 Years
- Secondary Outcome Measures
Name Time Method To prospectively evaluate the acute toxicity with the two treatments <br/ ><br>2. To prospectively evaluate the late toxicity with the two treatments <br/ ><br>3. To prospectively evaluate the disease related outcomes in the two cohortsTimepoint: 5 years