Focus Group Interviews of Patients With Permanent or Temporary Enterostomas

Empowerment Clinical Trial

Official title:

Patient Perspectives on Living With an Enterostoma and Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156506
• Other study ID #: AKD02
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: December 11, 2012
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2012
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Empowerment
• Living With an Enterostoma
• Mastery
• Patient Perspective

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Educational elements and themes that will optimize rehabilitation and patient education	Illumination and discussion of informants´ perspective on rehabilitation and patient education will	up until 10 months from interview	No
Secondary	Identification of strategies for improving quality of life	Illumination and discussion of informants perspective on the influence of an enterostoma on their lives	up until 10 months from interview	No