The Impact of Preoperative Urostomy Education on Patients and Families

Completed

• Conditions: Bladder Cancer; Urostomy
• Interventions: Other: Interview

• Registration Number: NCT04334226
• Lead Sponsor: University of Kansas Medical Center

Brief 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

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 Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-06
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient and Caregiver Dyad	Interview	Individuals who participated in the Stoma Boot Camp study and their caregiver will form a dyad

Primary Outcome Measures

Name	Time	Method
Impact of Stoma Bootcamp preoperative educational program on patients and caregivers	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

Trial Locations

Locations (1)

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States