Factors Influencing Patient Choice of Bladder Reconstruction Following Radical Cystectomy

NCT03325231 | Completed

• 1 other identifier: RIO 018-17
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• Bladder Reconstruction Satisfaction Questionnaire

  2 Years

• EORTC QLQ-30

  2 Years

• The Life Values Inventory

  2 Years

Study Arms (1)

Bladder Cancer Patients

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.

Other: Reconstructive surgery following bladder removal.

Interventions

Reconstructive surgery following bladder removal. OTHER

Investigating patient experience of bladder reconstructions.

Bladder Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Swansea University: lead
• Abertawe Bro Morgannwg University Health Board: collaborator

Study Sites (1)

Professor Phil Reed

Swansea, SA2 8PP, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: October 20, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)