NCT01156506

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

June 30, 2010

Last Update Submit

December 11, 2012

Conditions

Patient PerspectiveLiving With an EnterostomaMasteryEmpowerment

Keywords

quality of lifepatient educationrehabilitationfocus group interview

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Identification of strategies for improving quality of life

    up until 10 months from interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Department of surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Anne K. Danielsen, Nurse, MaClN

    Herlev University Hospital, department of surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d.student, RN

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 5, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 12, 2012

Record last verified: 2012-12