Clinical trial · Observational
Factors Influencing Patient Choice of Bladder Reconstruction Following Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radical cystectomy (bladder removal) after bladder cancer necessitates surgical reconstruction to allow urine drainage. Usually, this is achieved by either ileal conduit (a stoma leads to an external bag) or orthotopic neobladder (the creation of an artificial internal bladder). These treatments are most successful when tailored to the patient's own lifestyle needs. The current project will explore patient concerns, and the aspects of their lifestyles and values, that influence their choice of bladder reconstruction. It will also examine which of these concerns and values best predict satisfaction and enhanced QoL, following bladder reconstruction. Participants will be recruited from Health Board databases of those who have had advanced bladder cancer (grade pT1 and above) and undergone either IC or NB procedures within the last five years. 40 participants (equal numbers with each surgical procedure) will be randomly selected from the patient databases. They will be interviewed by a Researcher and a Clinical Nurse Specialist. A semi-structured interview will be conducted to ascertain patients' views about the key factors influencing their treatment decision and their satisfaction with the outcome. Approximately 200 participants (equal numbers with IC and NB) will be sent three questionnaires to assess their life values, QoL, and satisfaction with treatment: (1) Bladder Reconstruction Satisfaction Questionnaire measuring levels of satisfaction with bladder reconstruction; (2) EORTC QLQ-C30 measuring QoL in areas relevant to cancer patients; and (3) Life Values Inventory measuring values and lifestyles important to patients. Participants will be asked to complete the questionnaires and return them using a prepaid envelope. Participants will be provided with the contact details of a Clinical Nurse Specialist known to them to contact if they require help completing the questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reconstructive surgery following bladder removal. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bladder Cancer Patients
- description
- Participants will be recruited from those who have had advanced bladder cancer (grade pT1 and above) and undergone either IC or NB procedures within the last five years. No form of payment will be offered for participation, but participants will be reimbursed for travel expenses. There will be no other inclusion or exclusion criteria in order to access a wide range of patients with potentially different values and lifestyles, and to aid in the recruitment of adequate sample sizes.
- interventionNames
- Other: Reconstructive surgery following bladder removal.
Primary outcomes (3)
- measure
- Bladder Reconstruction Satisfaction Questionnaire
- timeFrame
- 2 Years
- measure
- EORTC QLQ-30
- timeFrame
- 2 Years
- measure
- The Life Values Inventory
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants will be recruited from those who have had advanced bladder cancer (grade pT1 and above) and undergone either ileal conduit (IC) or neobladder (NB) procedures within the last five years. There will be no other inclusion criteria in order to access a wide range of patients with potentially different values and lifestyles, and to aid in the recruitment of adequate sample sizes. Exclusion Criteria: * Anybody under the age of 18 years will be excluded. Apart from this, there will be no exclusion criteria in order to access a wide range of patients with potentially different values and lifestyles, and to aid in the recruitment of adequate sample sizes.
References
Publications (0)
Data not yet available