Addressing Barriers to Palliative Care Use in Bladder Cancer

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: Muscle-Invasive Bladder Carcinoma; Bladder Cancer Stage II; Bladder Cancer Stage III; Bladder Cancer Stage IV
• Intervention / Treatment: Other: Surveys

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

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	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	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	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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Scott Gilbert, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

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: Bladder
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• 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