Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Change in Cancer-specific Health-related quality of life [From baseline up to 1 year]
Assessed with the EORTC-qlq-c30
- Change in Bladder cancer-specific Health-related quality of life [From baseline up to 1 year]
Assessed with the EORTC-qlq-blm30
- Change in Psychological distress [From baseline up to 1 year]
Assessed with the distress thermometer
- Change in problems associated with psychological distress [From baseline up to 1 year]
Assessed with the problem list
- Health literacy [Baseline]
Assessed with the BRIEF Health Literacy Screening Tool
- Change in Physical activity pattern [From baseline up to 1 year]
Assessed with the Godin Leisure-Time Exercise Questionnaire
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age is 18 years or older
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Patients diagnosed with bladder cancer who will undergo radical cystectomy
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Patient has to be able to sign informed consent
Exclusion Criteria:
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Metastatic cancer
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ghent University | Ghent | Belgium |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Valérie Fonteyne, MD, PhD, Gent University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC/2017/0350