Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

NCT ID: NCT03307200

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2021-08-27

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.

Detailed Description

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Conditions

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Bladder Cancer Urologic Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie Fonteyne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gent University

Locations

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Ghent University

Ghent, , Belgium

Site Status

University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 34449941 (View on PubMed)

Other Identifiers

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EC/2017/0350

Identifier Type: -

Identifier Source: org_study_id

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