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Completed

NCT Number: NCT04334226

The Impact of Preoperative Urostomy Education on Patients and Families

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: StomABC Impact

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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