- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01156506
Focus Group Interviews of Patients With Permanent or Temporary Enterostomas
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
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Anne K. Danielsen, Nurse, MaClN, Herlev University Hospital, department of surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AKD02
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
-
Hacettepe UniversityRecruitingPatient Perspective | Systemic Sclerosis (SSc) | Scleroderma (Limited and Diffuse) | Systemic Sclerosis (Scleroderma)Turkey (Türkiye)
-
East and North Hertfordshire NHS TrustRecruitingDialysis | Perspective of Healthcare Professionals Haemodialysis NeedlingUnited Kingdom
-
University of AarhusUnknownPatient Engagement | Patient Empowerment | Patient Compliance
-
CalydialOZ'IRIS SantéCompletedPatient Engagement | Patient Participation | Patient Satisfaction | Dialysis | Patient Relations, Nurse | Experience, LifeFrance
-
The University of Texas at ArlingtonAgency for Healthcare Research and Quality (AHRQ)CompletedPatient Engagement | Patient Empowerment | Patient ActivationUnited States
-
University of California, San DiegoPatient-Centered Outcomes Research Institute; University of Massachusetts,... and other collaboratorsCompletedPatient Engagement | Physician-Patient Relations | Physician's Role | Patient ActivationUnited States
-
Rush University Medical CenterCompletedPatient Discharge | Patient AdmissionUnited States
-
Rush University Medical CenterCompletedPatient Discharge | Patient AdmissionUnited States
-
Universitair Ziekenhuis BrusselWithdrawnPatient Satisfaction | Patient PreferenceBelgium
-
Cedars-Sinai Medical CenterTerminated