Muscle-Invasive Bladder CarcinomaNCT04598724
Addressing Barriers to Palliative Care Use in Bladder Cancer
An observational study of Muscle-Invasive Bladder Carcinoma and Bladder Cancer Stage II, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
Investigators plan to establish an in-depth understanding of knowledge and beliefs about palliative care in advanced Bladder Cancer patients and their caregivers, and to identify factors associated with positive and negative experiences with palliative care services among those who have received them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer Stage II, Bladder Cancer Stage III
- What is being tested?
- Surveys
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 10 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bladder Cancer patient participants and care givers will be recruited from the Moffitt Cancer Genitourinary Oncology clinic and the Supportive Care clinic.
Who may be able to join
- Eligibility for both patient and caregiver participants will include:
- age ≥18 years
- able to speak and read English
- cognitively able to participate in study tasks
- willing to participate in surveys, semi-structured interviews, and/or focus groups
- able to participate in either a Zoom meeting or phone interview
- able to complete an emailed or paper survey
- Patient Participants: a diagnosis of muscle-invasive or locally advanced bladder cancer (stages II-IV).
Who cannot join
- Patients and caregivers will be excluded if unable to provide verbal or written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Barriers to Palliative Care Use in Bladder Cancer Through Better Understanding of Knowledge and Belief Development
Investigators plan to establish an in-depth understanding of knowledge and beliefs about palliative care in advanced Bladder Cancer patients and their caregivers, and to identify factors associated with positive and negative experiences with palliative care services among those who have received them.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer Stage II, Bladder Cancer Stage III, Bladder Cancer Stage IV
- Being tested
- Surveys
- Keywords
- Bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Survey will be administered involving questions regarding knowledge and perception of palliative care.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Patient Participants | Participants will be scheduled for one-on-one interviews that will occur over Zoom or telephone. Receives: Other: Surveys | |
| Care Givers for Bladder Cancer Patient Participants | Participants will be scheduled for one-on-one interviews that will occur over Zoom or telephone. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of palliative care knowledge and beliefs
Thematic analysis of interviews transcriptions to identify the themes that underpin the development of palliative care beliefs among patients with muscle invasive bladder cancer.
Measured: 12 Months
Proportion with accurate palliative care knowledge and beliefs
Proportion of patients correctly answering each palliative care knowledge question.
Measured: 12 Months
Secondary outcomes (1)
Association between Bladder Cancer stage and palliative care knowledge
Analysis of variance calculated for the mean number of subjects with each cancer stage correctly answering each palliative care knowledge question
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Dec 2020
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Gilbert, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598724
- Sponsor's protocol ID
- MCC-20809
- Status last verified
- Dec 2022
- First submitted
- 16 Oct 2020
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Palliative Care Use in Bladder Cancer Through Better Understanding of Knowledge and Belief Development
- ClinicalTrials.gov ID
- NCT04598724
- Acronym / sponsor ID
- MCC-20809
- Conditions
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer Stage II, Bladder Cancer Stage III, Bladder Cancer Stage IV
- Keywords
- Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 22 Oct 2020 (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.
Investigators plan to establish an in-depth understanding of knowledge and beliefs about palliative care in advanced Bladder Cancer patients and their caregivers, and to identify factors associated with positive and negative experiences with palliative care services among those who have received them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patient Participants | – | Other: SurveysParticipants will be scheduled for one-on-one interviews that will occur over Zoom or telephone. |
| Care Givers for Bladder Cancer Patient Participants | – | Other: SurveysParticipants will be scheduled for one-on-one interviews that will occur over Zoom or telephone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bladder Cancer patient participants and care givers will be recruited from the Moffitt Cancer Genitourinary Oncology clinic and the Supportive Care clinic.
Key inclusion criteria (8 listed)
- Eligibility for both patient and caregiver participants will include:
- age ≥18 years
- able to speak and read English
- cognitively able to participate in study tasks
- willing to participate in surveys, semi-structured interviews, and/or focus groups
Key exclusion criteria (1 listed)
- Patients and caregivers will be excluded if unable to provide verbal or written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysSurvey will be administered involving questions regarding knowledge and perception of palliative care. | Other | Bladder Cancer Patient Participants, Care Givers for Bladder Cancer Patient Participants |
Primary outcome
Development of palliative care knowledge and beliefs
Time frame: 12 Months
Thematic analysis of interviews transcriptions to identify the themes that underpin the development of palliative care beliefs among patients with muscle invasive bladder cancer.
Proportion with accurate palliative care knowledge and beliefs
Time frame: 12 Months
Proportion of patients correctly answering each palliative care knowledge question.
1 secondary outcome
Association between Bladder Cancer stage and palliative care knowledge
Time frame: 12 Months
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 3 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Scott Gilbert, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-Invasive Bladder Carcinoma and Bladder Cancer Stage II, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 8 inclusion and 1 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 3 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 1 site in United States. 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?
Development of palliative care knowledge and beliefs (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2023.