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Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

This study is currently recruiting participants.
Verified October 2017 by Radiotherapie, University Ghent
Sponsor:
ClinicalTrials.gov Identifier:
NCT03307200
First Posted: October 11, 2017
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Radiotherapie, University Ghent
  Purpose
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.

Condition
Bladder Cancer Urologic Cancer Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy

Resource links provided by NLM:


Further study details as provided by Radiotherapie, University Ghent:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Change in Cancer-specific Health-related quality of life [ Time Frame: From baseline up to 1 year ]
    Assessed with the EORTC-qlq-c30

  • Change in Bladder cancer-specific Health-related quality of life [ Time Frame: From baseline up to 1 year ]
    Assessed with the EORTC-qlq-blm30

  • Change in Psychological distress [ Time Frame: From baseline up to 1 year ]
    Assessed with the distress thermometer

  • Change in problems associated with psychological distress [ Time Frame: From baseline up to 1 year ]
    Assessed with the problem list

  • Health literacy [ Time Frame: Baseline ]
    Assessed with the BRIEF Health Literacy Screening Tool

  • Change in Physical activity pattern [ Time Frame: From baseline up to 1 year ]
    Assessed with the Godin Leisure-Time Exercise Questionnaire

  • 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.

  • 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.


Estimated Enrollment: 40
Actual Study Start Date: April 3, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with bladder cancer who will undergo radical cystectomy
Criteria

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
  Contacts and Locations
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): NCT03307200


Contacts
Contact: Elke Rammant, MSc 09 332 15 52 elke.rammant@uzgent.be

Locations
Belgium
Ghent University Recruiting
Ghent, Belgium
Contact: Elke Rammant, MSc         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Valérie Fonteyne, MD, PhD Gent University
  More Information

Responsible Party: Radiotherapie, Prof. Dr. Valérie Fonteyne, University Ghent
ClinicalTrials.gov Identifier: NCT03307200     History of Changes
Other Study ID Numbers: EC/2017/0350
First Submitted: September 22, 2017
First Posted: October 11, 2017
Last Update Posted: October 11, 2017
Last Verified: October 2017

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

Keywords provided by Radiotherapie, University Ghent:
Supportive care
Prospective observational study

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