Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Focus Group Interviews of Patients With Permanent or Temporary Enterostomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Kjærgaard Danielsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01156506
First received: June 30, 2010
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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
Patient Perspective
Living With an Enterostoma
Mastery
Empowerment

Study Type: Observational
Official Title: Patient Perspectives on Living With an Enterostoma and Rehabilitation

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Educational elements and themes that will optimize rehabilitation and patient education [ Time Frame: up until 10 months from interview ] [ Designated as safety issue: No ]
    Illumination and discussion of informants´ perspective on rehabilitation and patient education will


Secondary Outcome Measures:
  • Identification of strategies for improving quality of life [ Time Frame: up until 10 months from interview ] [ Designated as safety issue: No ]
    Illumination and discussion of informants perspective on the influence of an enterostoma on their lives


Enrollment: 22
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Department of surgery

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156506

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

No publications provided

Responsible Party: Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01156506     History of Changes
Other Study ID Numbers: AKD02
Study First Received: June 30, 2010
Last Updated: December 11, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
quality of life
patient education
rehabilitation
focus group interview

ClinicalTrials.gov processed this record on November 25, 2014