The Impact of Preoperative Urostomy Education on Patients and Families

Bladder Cancer Clinical Trial

— StomABC Impact  

Official title:

The Impact of Preoperative Urostomy Education on Patients and Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334226
• Other study ID #: 145269
• Status: Completed
• Start date: March 3, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms
• Urostomy

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Stoma Bootcamp preoperative educational program on patients and caregivers	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