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CompletedNCT03307200Updated Jan 5, 2023

Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

An observational study in Bladder Cancer, Urologic Cancer and Surgery, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Cancer
  • Urologic Cancer
  • Surgery

Keywords

  • Supportive care
  • Prospective observational study
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients diagnosed with bladder cancer who will undergo radical cystectomy

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Change in Unmet supportive care needs

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

    Time frame: From baseline up to 1 year

Secondary outcomes

  1. Change in Cancer-specific Health-related quality of life

    Assessed with the EORTC-qlq-c30

    Time frame: From baseline up to 1 year

  2. Change in Bladder cancer-specific Health-related quality of life

    Assessed with the EORTC-qlq-blm30

    Time frame: From baseline up to 1 year

  3. Change in Psychological distress

    Assessed with the distress thermometer

    Time frame: From baseline up to 1 year

  4. Change in problems associated with psychological distress

    Assessed with the problem list

    Time frame: From baseline up to 1 year

  5. Health literacy

    Assessed with the BRIEF Health Literacy Screening Tool

    Time frame: Baseline

  6. Change in Physical activity pattern

    Assessed with the Godin Leisure-Time Exercise Questionnaire

    Time frame: From baseline up to 1 year

  7. Change in Physical Activity Stage of change

    Assessed with a questionnaire based on an algorithm made by Marcus et al.

    Time frame: From baseline up to 1 year

  8. Change in The use of health care services

    Separate questions where the patient is asked about his/her use of supportive health care services.

    Time frame: From baseline up to 1 year

06

Study locations

2 sites
  • Ghent University
    Ghent, Belgium
  • University Hospitals Leuven
    Leuven, 3000, Belgium
07

References and documents

Publications

  • 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. PubMed 34449941 ↗
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Registry details

Key details

Study ID
NCT03307200
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Apr 3, 2017
Primary completion
Dec 31, 2020
Completion
Aug 27, 2021
Last update
Jan 5, 2023

Study contacts

Valérie Fonteyne, MD, PhD
principal investigator · Gent University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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