Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

January 3, 2023 updated by: University Hospital, Ghent

A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy

Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Ghent University
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with bladder cancer who will undergo radical cystectomy

Description

Inclusion Criteria:

  • age is 18 years or older
  • Patients diagnosed with bladder cancer who will undergo radical cystectomy
  • Patient has to be able to sign informed consent

Exclusion Criteria:

  • Metastatic cancer
  • Presence of a second primary tumor with the exception of fully deleted prostate cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Unmet supportive care needs
Time Frame: From baseline up to 1 year
Assessed with the 34-item supportive care needs survey (SCNS-34)
From baseline up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cancer-specific Health-related quality of life
Time Frame: From baseline up to 1 year
Assessed with the EORTC-qlq-c30
From baseline up to 1 year
Change in Bladder cancer-specific Health-related quality of life
Time Frame: From baseline up to 1 year
Assessed with the EORTC-qlq-blm30
From baseline up to 1 year
Change in Psychological distress
Time Frame: From baseline up to 1 year
Assessed with the distress thermometer
From baseline up to 1 year
Change in problems associated with psychological distress
Time Frame: From baseline up to 1 year
Assessed with the problem list
From baseline up to 1 year
Health literacy
Time Frame: Baseline
Assessed with the BRIEF Health Literacy Screening Tool
Baseline
Change in Physical activity pattern
Time Frame: From baseline up to 1 year
Assessed with the Godin Leisure-Time Exercise Questionnaire
From baseline up to 1 year
Change in Physical Activity Stage of change
Time Frame: From baseline up to 1 year
Assessed with a questionnaire based on an algorithm made by Marcus et al.
From baseline up to 1 year
Change in The use of health care services
Time Frame: From baseline up to 1 year
Separate questions where the patient is asked about his/her use of supportive health care services.
From baseline up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Valérie Fonteyne, MD, PhD, Gent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2017/0350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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