The Impact of Preoperative Urostomy Education on Patients and Families (StomABC Impact)

March 3, 2021 updated by: Elizabeth Wulff-Burchfield, MD, University of Kansas Medical Center
This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will utilize a qualitative descriptive methodology with a thematic analysis approach. Individual interviews will be held with bladder cancer and caregiver dyads who participated in the Stoma Bootcamp study. Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective. Semi-structured interview guides will be developed using Engel Biopsychosocial Model (BPS),5 one guide geared towards patients and the second toward caregivers.

Study Type

Observational

Enrollment (Actual)

16

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
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas 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

Patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center and participated in Stoma Botcamp and their caregivers

Description

Inclusion Criteria:

  • Adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center since 2016, AND
  • Participated in the Stoma Bootcamp preoperative educational intervention, AND
  • Identified an informal/family caregiver who participated in Stoma Bootcamp with them.
  • Patient-caregiver dyads must both consent to participation

Exclusion Criteria:

-

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
Patient and Caregiver Dyad
Individuals who participated in the Stoma Boot Camp study and their caregiver will form a dyad
Other: Interview
Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Stoma Bootcamp preoperative educational program on patients and caregivers
Time Frame: Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year
The research team will open code a subset of interviews, develop a codebook, and continue rounds of coding and discussion until consensus on code and definitions is reached. Once consensus is reached, all transcripts will be coded using the codebook, categories will be developed, and emergent themes will be assessed. Once themes are identified, they will be placed into a thematic map. Data will be analyzed until thematic saturation is reached
Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year

Collaborators and Investigators

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

Sponsor

University of Kansas Medical Center

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)

March 3, 2020

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145269

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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