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Focus Group Interviews of Patients With Permanent or Temporary Enterostomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01156506
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):
Anne Kjærgaard Danielsen, Herlev Hospital

Brief Summary:

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.

Condition or disease
Patient Perspective Living With an Enterostoma Mastery Empowerment

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
Actual Enrollment : 22 participants
Official Title: Patient Perspectives on Living With an Enterostoma and Rehabilitation
Study Start Date : February 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Department of surgery

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156506

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

Responsible Party: Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01156506     History of Changes
Other Study ID Numbers: AKD02
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Anne Kjærgaard Danielsen, Herlev Hospital:
quality of life
patient education
focus group interview