Clinical trial NCT03307200: Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy
Official title: A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Urologic Cancer
Surgery
Keywords: Supportive care
Prospective observational study
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with bladder cancer who will undergo radical cystectomy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Unmet supportive care needs
timeFrame: From baseline up to 1 year
Secondary outcomes:
measure: Change in Cancer-specific Health-related quality of life
timeFrame: From baseline up to 1 year
measure: Change in Bladder cancer-specific Health-related quality of life
timeFrame: From baseline up to 1 year
measure: Change in Psychological distress
timeFrame: From baseline up to 1 year
measure: Change in problems associated with psychological distress
timeFrame: From baseline up to 1 year
measure: Health literacy
timeFrame: Baseline
measure: Change in Physical activity pattern
timeFrame: From baseline up to 1 year
measure: Change in Physical Activity Stage of change
timeFrame: From baseline up to 1 year
measure: Change in The use of health care services
timeFrame: From baseline up to 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Gent University
name: Valérie Fonteyne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rammant E, Van Hecke A, Decaestecker K, Albersen M, Joniau S, Everaerts W, Jansen F, Mohamed NE, Colman R, Van Hemelrijck M, Fonteyne V. Supportive care needs and utilization of bladder cancer patients undergoing radical cystectomy: A longitudinal study. Psychooncology. 2022 Feb;31(2):219-226. doi: 10.1002/pon.5795. Epub 2021 Aug 27.