Addressing Barriers to Palliative Care Use in Bladder Cancer

December 30, 2022 updated by: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bladder Cancer patient participants and care givers will be recruited from the Moffitt Cancer Genitourinary Oncology clinic and the Supportive Care clinic.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Patients and caregivers will be excluded if unable to provide verbal or written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bladder Cancer Patient Participants
Participants will be scheduled for one-on-one interviews that will occur over Zoom or telephone.
Other: Surveys
Survey will be administered involving questions regarding knowledge and perception of palliative care.
Care Givers for Bladder Cancer Patient Participants
Participants will be scheduled for one-on-one interviews that will occur over Zoom or telephone.
Other: Surveys
Survey will be administered involving questions regarding knowledge and perception of palliative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
Proportion with accurate palliative care knowledge and beliefs
Time Frame: 12 Months
Proportion of patients correctly answering each palliative care knowledge question.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Bladder Cancer stage and palliative care knowledge
Time Frame: 12 Months
Analysis of variance calculated for the mean number of subjects with each cancer stage correctly answering each palliative care knowledge question
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Scott Gilbert, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

May 10, 2021

Study Completion (Actual)

May 10, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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