The Impact of Preoperative Urostomy Education on Patients and Families

NCT04334226 | Completed

• 1 other identifier: 145269
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Bladder Cancer; Urostomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient and Caregiver Dyad

Individuals who participated in the Stoma Boot Camp study and their caregiver will form a dyad

Other: Interview

Interventions

Interview OTHER

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

Patient and Caregiver Dyad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medical Oncology

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: March 3, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)