Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Completed

• Conditions: Urologic Cancer; Surgery; Bladder Cancer

• Registration Number: NCT03307200
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-08-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Unmet supportive care needs	From baseline up to 1 year	Assessed with the 34-item supportive care needs survey (SCNS-34)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ghent University; 🇧🇪 Ghent, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium