Focus Group Interviews of Patients With Permanent or Temporary Enterostomas

December 11, 2012 updated by: Anne Kjærgaard Danielsen, Herlev Hospital

Patient Perspectives on Living With an Enterostoma and Rehabilitation

The study seeks to gain knowledge about new and of alternative ways of organizing ostomy training based on informants' own experiences of life with a stoma.

The study is designed and conducted as qualitative focus group interviews with three different groups of patients with enterostomas (5-8 in each group): a) people with permanent enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3) people with a temporary ileostomy.

Study Overview

Detailed Description

The study is investigating the perspective of the patients who have actually experienced having surgery and living with an enterostoma.

By applying this method it is possible to gain access and in depth knowledge of complex issues including sensitive data. The dialogue with peers can lead to experiments and associations which might stimulate the informants to produce new insights within the individual and in the group.

The interviews will be transcribed in full and analyzed with qualitative content analysis with a phenomenological and hermeneutical approach

Study Type

Observational

Enrollment (Actual)

22

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

Department of surgery

Description

Inclusion Criteria:

  • Patients with permanent enterostoma due to cancer.
  • Patients with permanent enterostoma due to other causes.
  • Patients with temporary ileostomy.

Exclusion Criteria:

  • Patients with severe mental disorders.
  • Patients who do not communicate in Danish.
  • Patients with severe hearing impairment.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Educational elements and themes that will optimize rehabilitation and patient education
Time Frame: up until 10 months from interview
Illumination and discussion of informants´ perspective on rehabilitation and patient education will
up until 10 months from interview

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of strategies for improving quality of life
Time Frame: up until 10 months from interview
Illumination and discussion of informants perspective on the influence of an enterostoma on their lives
up until 10 months from interview

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Anne K. Danielsen, Nurse, MaClN, Herlev University Hospital, department of surgery

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

February 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

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.

Clinical Trials on Patient Perspective

Subscribe