Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

NCT03307200 | Completed

• 1 other identifier: EC/2017/0350
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Urologic Cancer; Surgery

Keywords

Supportive care; Prospective observational study

Outcome Measures

Primary Outcomes (1)

• Change in Unmet supportive care needs

  Assessed with the 34-item supportive care needs survey (SCNS-34)

  From baseline up to 1 year

Secondary Outcomes (8)

• Change in Cancer-specific Health-related quality of life

  From baseline up to 1 year

• Change in Bladder cancer-specific Health-related quality of life

  From baseline up to 1 year

• Change in Psychological distress

  From baseline up to 1 year

• Change in problems associated with psychological distress

  From baseline up to 1 year

• Health literacy

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with bladder cancer who will undergo radical cystectomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University

Ghent, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34449941 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Valérie Fonteyne, MD, PhD

  Gent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 11, 2017
• Study Start: April 3, 2017
• Primary Completion: December 31, 2020
• Study Completion: August 27, 2021
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

BE (2)