Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer, Urologic Cancer, Surgery

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unmet supportive care needs | 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 | Assessed with the EORTC-qlq-c30 | From baseline up to 1 year | 
| Change in Bladder cancer-specific Health-related quality of life | Assessed with the EORTC-qlq-blm30 | From baseline up to 1 year | 
| Change in Psychological distress | Assessed with the distress thermometer | From baseline up to 1 year | 
| Change in problems associated with psychological distress | Assessed with the problem list | From baseline up to 1 year | 
| Health literacy | Assessed with the BRIEF Health Literacy Screening Tool | Baseline | 
| Change in Physical activity pattern | Assessed with the Godin Leisure-Time Exercise Questionnaire | From baseline up to 1 year | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive care, Prospective observational study