NCT04598724

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

October 16, 2020

Last Update Submit

December 30, 2022

Conditions

Keywords

Bladder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Association between Bladder Cancer stage and palliative care knowledge

    12 Months

Study Arms (2)

Bladder Cancer Patient Participants

Participants will be scheduled for one-on-one interviews that will occur over Zoom or telephone.

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.

Other: Surveys

Interventions

SurveysOTHER

Survey will be administered involving questions regarding knowledge and perception of palliative care.

Bladder Cancer Patient ParticipantsCare Givers for Bladder Cancer Patient Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Scott Gilbert, MD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

December 22, 2020

Primary Completion

May 10, 2021

Study Completion

May 10, 2021

Last Updated

January 3, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations