Patient PerspectiveNCT01156506
Focus Group Interviews of Patients With Permanent or Temporary Enterostomas
An observational study of Patient Perspective and Living With an Enterostoma, run by Herlev Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Perspective, Living With an Enterostoma, Mastery
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of surgery
Who may be able to join
- Patients with permanent enterostoma due to cancer.
- Patients with permanent enterostoma due to other causes.
- Patients with temporary ileostomy.
Who cannot join
- Patients with severe mental disorders.
- Patients who do not communicate in Danish.
- Patients with severe hearing impairment.
About this study
Official title: 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.
Read the 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
- Conditions
- Patient Perspective, Living With an Enterostoma, Mastery, Empowerment
- Keywords
- quality of life, patient education, rehabilitation, focus group interview
- Medical subject headings
- Empowerment
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational elements and themes that will optimize rehabilitation and patient education
Illumination and discussion of informants´ perspective on rehabilitation and patient education will
Measured: up until 10 months from interview
Secondary outcomes (1)
Identification of strategies for improving quality of life
Illumination and discussion of informants perspective on the influence of an enterostoma on their lives
Measured: up until 10 months from interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PerspectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kjærgaard Danielsen, Herlev Hospital
- Investigators
- Anne K. Danielsen, Nurse, MaClN, Principal investigator, Herlev University Hospital, department of surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156506
- Sponsor's protocol ID
- AKD02
- Status last verified
- Dec 2012
- First submitted
- 30 Jun 2010
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives on Living With an Enterostoma and Rehabilitation
- ClinicalTrials.gov ID
- NCT01156506
- Acronym / sponsor ID
- AKD02
- Conditions
- Patient Perspective, Living With an Enterostoma, Mastery, Empowerment
- Keywords
- quality of life, patient education, rehabilitation, focus group interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of surgery
Key inclusion criteria (3 listed)
- Patients with permanent enterostoma due to cancer.
- Patients with permanent enterostoma due to other causes.
- Patients with temporary ileostomy.
Key exclusion criteria (3 listed)
- Patients with severe mental disorders.
- Patients who do not communicate in Danish.
- Patients with severe hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Identification of strategies for improving quality of life
Time frame: up until 10 months from interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K. Danielsen, Nurse, MaClN principal investigator
Herlev University Hospital, department of surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Perspective and Living With an Enterostoma, run by Herlev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Educational elements and themes that will optimize rehabilitation and patient education (time frame: up until 10 months from interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.