Bladder CancerNCT03307200
Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy
An observational study of Bladder Cancer and Urologic Cancer, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urologic Cancer, Surgery
- How many people
- 90 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Apr 2017to 27 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with bladder cancer who will undergo radical cystectomy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy
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
- Medical subject headings
- Urinary Bladder Neoplasms, Urologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unmet supportive care needs
Assessed with the 34-item supportive care needs survey (SCNS-34)
Measured: From baseline up to 1 year
Secondary outcomes (8)
Change in Cancer-specific Health-related quality of life
Assessed with the EORTC-qlq-c30
Measured: From baseline up to 1 year
Change in Bladder cancer-specific Health-related quality of life
Assessed with the EORTC-qlq-blm30
Measured: From baseline up to 1 year
Change in Psychological distress
Assessed with the distress thermometer
Measured: From baseline up to 1 year
Change in problems associated with psychological distress
Assessed with the problem list
Measured: From baseline up to 1 year
Health literacy
Assessed with the BRIEF Health Literacy Screening Tool
Measured: Baseline
Change in Physical activity pattern
Assessed with the Godin Leisure-Time Exercise Questionnaire
Measured: From baseline up to 1 year
Change in Physical Activity Stage of change
Assessed with a questionnaire based on an algorithm made by Marcus et al.
Measured: From baseline up to 1 year
Change in The use of health care services
Separate questions where the patient is asked about his/her use of supportive health care services.
Measured: From baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start3 Apr 2017
- Primary completion31 Dec 2020
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Fonteyne, MD, PhD, Principal investigator, Gent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307200
- Sponsor's protocol ID
- EC/2017/0350
- Status last verified
- Jan 2023
- First submitted
- 22 Sep 2017
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03307200
- Acronym / sponsor ID
- EC/2017/0350
- Conditions
- Bladder Cancer, Urologic Cancer, Surgery
- Keywords
- Supportive care, Prospective observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bladder cancer who will undergo radical cystectomy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Unmet supportive care needs
Time frame: From baseline up to 1 year
Assessed with the 34-item supportive care needs survey (SCNS-34)
8 secondary outcomes
Change in Cancer-specific Health-related quality of life
Time frame: From baseline up to 1 year
Change in Bladder cancer-specific Health-related quality of life
Time frame: From baseline up to 1 year
Change in Psychological distress
Time frame: From baseline up to 1 year
Change in problems associated with psychological distress
Time frame: From baseline up to 1 year
Health literacy
Time frame: Baseline
Change in Physical activity pattern
Time frame: From baseline up to 1 year
Change in Physical Activity Stage of change
Time frame: From baseline up to 1 year
Change in The use of health care services
Time frame: From baseline up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 34449941Rammant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Fonteyne, MD, PhD principal investigator
Gent University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urologic Cancer, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unmet supportive care needs (time frame: From baseline up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.