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Factors Influencing Patient Choice of Bladder Reconstruction Following Radical Cystectomy

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ClinicalTrials.gov Identifier: NCT03325231
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Abertawe Bro Morgannwg University Health Board
Information provided by (Responsible Party):
Prof Phil Reed, Swansea University

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.

Condition or disease Intervention/treatment
Bladder Cancer Other: Reconstructive surgery following bladder removal.

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Influencing Patient Choice of Bladder Reconstruction Following Radical Cystectomy
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Investigating patient experience of bladder reconstructions.




Primary Outcome Measures :
  1. Bladder Reconstruction Satisfaction Questionnaire [ Time Frame: 2 Years ]
  2. EORTC QLQ-30 [ Time Frame: 2 Years ]
  3. The Life Values Inventory [ Time Frame: 2 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325231


Locations
United Kingdom
Professor Phil Reed Recruiting
Swansea, United Kingdom, SA2 8PP
Contact: Phil Reed, D.Phil.    0044 (0)1792 602047    p.reed@swansea.ac.uk   
Sponsors and Collaborators
Swansea University
Abertawe Bro Morgannwg University Health Board

Responsible Party: Prof Phil Reed, Professor, Swansea University
ClinicalTrials.gov Identifier: NCT03325231     History of Changes
Other Study ID Numbers: RIO 018-17
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases