Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307200
• Other study ID #: EC/2017/0350
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: August 27, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 27, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Surgery
• Urinary Bladder Neoplasms
• Urologic Cancer
• Urologic Neoplasms

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Unmet supportive care needs	Assessed with the 34-item supportive care needs survey (SCNS-34)	From baseline up to 1 year
Secondary	Change in Cancer-specific Health-related quality of life	Assessed with the EORTC-qlq-c30	From baseline up to 1 year
Secondary	Change in Bladder cancer-specific Health-related quality of life	Assessed with the EORTC-qlq-blm30	From baseline up to 1 year
Secondary	Change in Psychological distress	Assessed with the distress thermometer	From baseline up to 1 year
Secondary	Change in problems associated with psychological distress	Assessed with the problem list	From baseline up to 1 year
Secondary	Health literacy	Assessed with the BRIEF Health Literacy Screening Tool	Baseline
Secondary	Change in Physical activity pattern	Assessed with the Godin Leisure-Time Exercise Questionnaire	From baseline up to 1 year
Secondary	Change in Physical Activity Stage of change	Assessed with a questionnaire based on an algorithm made by Marcus et al.	From baseline up to 1 year
Secondary	Change in The use of health care services	Separate questions where the patient is asked about his/her use of supportive health care services.	From baseline up to 1 year