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Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03307200
Enrollment
90
Registered
2017-10-11
Start date
2017-04-03
Completion date
2021-08-27
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Surgery, Urologic Cancer

Keywords

Supportive care, Prospective observational study

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.

Interventions

None listed

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Unmet supportive care needsFrom baseline up to 1 yearAssessed with the 34-item supportive care needs survey (SCNS-34)

Secondary

MeasureTime frameDescription
Change in Bladder cancer-specific Health-related quality of lifeFrom baseline up to 1 yearAssessed with the EORTC-qlq-blm30
Change in Psychological distressFrom baseline up to 1 yearAssessed with the distress thermometer
Change in problems associated with psychological distressFrom baseline up to 1 yearAssessed with the problem list
Change in Cancer-specific Health-related quality of lifeFrom baseline up to 1 yearAssessed with the EORTC-qlq-c30
Change in Physical activity patternFrom baseline up to 1 yearAssessed with the Godin Leisure-Time Exercise Questionnaire
Change in Physical Activity Stage of changeFrom baseline up to 1 yearAssessed with a questionnaire based on an algorithm made by Marcus et al.
Change in The use of health care servicesFrom baseline up to 1 yearSeparate questions where the patient is asked about his/her use of supportive health care services.
Health literacyBaselineAssessed with the BRIEF Health Literacy Screening Tool

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026