Intestinal CancerrctNCT05809661
Implementation of the Nurse Navigation Program
An observational study of Intestinal Cancer, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Cancer
- What is being tested?
- implementation of the nurse navigation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2021
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with intestinal stoma
Who may be able to join
- Having no mental handicap or perception problems and no communication difficulties
- No psychiatric disease
- 18 years old and over
- literate
- Capable of using a smartphone
- No vision and hearing problems
- Those who have the physical ability to change the stoma bag themselves.
- Patients with intestinal stoma for a maximum of two months were included in the study.
Who cannot join
- After agreeing to participate in the research, wanting to leave,
- Those who died during the research process,
- The stoma was closed during the research process,
- Patients whose communication could not be maintained during the research process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: İnvestigation of the Effect on Nurse Navigation Program on Compliance, Quality of Life and Prevention of Complications in Patients With Stoma
This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care
Read the detailed description
This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care. The patients were evaluated using the Patient Information Form, Stoma Complications Evaluation Form, Stoma-Related Problems Experienced Form, Ostomy Compliance Scale, and Stoma Quality of Life Scale at the first interview, at the third and sixth months.
- Conditions
- Intestinal Cancer
- Being tested
- implementation of the nurse navigation program
- Keywords
- Nursing, Navigation Program, Stoma, Compliance
- Medical subject headings
- Intestinal Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of the nurse navigation programBehavioural
Adult patients with intestinal stoma were contacted continuously for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| deney grubu | adult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. The training booklet was delivered to them. Their contact information was obtained and the contact information of the researcher (navigator nurse) was shared with them. They were told that they could call the navigator nurse, send a message to him/her, take a photo of the stoma and share it with his/her when necessary, when they had physical, social, and psychological problems in the stoma or in line with their changing needs. In the next 3 months, they were informed about the applications to be made within the scope of the study (phone calls, information messages and videos, guidance and appointment planning). Appointment was scheduled for the next interview in 3 months.
. Receives: Behavioral: implementation of the nurse navigation program | |
| kontrol grubu | adult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. All of the data collection tools were filled out. Their questions about stoma care were answered. Training booklet was handed down to them. An appointment was scheduled for the next interview 3 months later. The second interview (3 months after the first interview): A few days before the interview, they were called up and reminded of their appointment. The relevant forms were filled out with them at the end of the 3rd month. Their questions about stoma care were answered. An appointment was scheduled for the next interview 3 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stoma compliance
stoma compliance scale
Measured: 6 month
Secondary outcomes (1)
life quality
quality of life scale
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal CancerStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülistan YURDAGÜL, Kilis 7 Aralik University
- Investigators
- nuran tosun, prof, Study director, nuran.tosun@hku.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809661
- Sponsor's protocol ID
- 19862023
- Acronym
- rct
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yurdagul G, Tosun N. Examining the effect of nurse navigation programme on stoma adjustment, quality of life, and prevention of complications in patients with stoma: a randomized controlled trial. BMC Gastroenterol. 2026 Jul 3. doi: 10.1186/s12876-026-05073-0. Online ahead of print.
PubMed 42399788
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İnvestigation of the Effect on Nurse Navigation Program on Compliance, Quality of Life and Prevention of Complications in Patients With Stoma
- ClinicalTrials.gov ID
- NCT05809661
- Acronym / sponsor ID
- rct / 19862023
- Conditions
- Intestinal Cancer
- Keywords
- Nursing, Navigation Program, Stoma, Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Apr 2023 (actual)
- 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.
This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care
Detailed description
This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care. The patients were evaluated using the Patient Information Form, Stoma Complications Evaluation Form, Stoma-Related Problems Experienced Form, Ostomy Compliance Scale, and Stoma Quality of Life Scale at the first interview, at the third and sixth months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deney grubu | – | Behavioral: implementation of the nurse navigation programadult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. The training booklet was delivered to them. Their contact information was obtained and the contact information of the researcher (navigator nurse) was shared with them. They were told that they could call the navigator nurse, send a message to him/her, take a photo of the stoma and share it with his/her when necessary, when they had physical, social, and psychological problems in the stoma or in line with their changing needs. In the next 3 months, they were informed about the applications to be made within the scope of the study (phone calls, information messages and videos, guidance and appointment planning). Appointment was scheduled for the next interview in 3 months. . |
| kontrol grubu | – | –adult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. All of the data collection tools were filled out. Their questions about stoma care were answered. Training booklet was handed down to them. An appointment was scheduled for the next interview 3 months later. The second interview (3 months after the first interview): A few days before the interview, they were called up and reminded of their appointment. The relevant forms were filled out with them at the end of the 3rd month. Their questions about stoma care were answered. An appointment was scheduled for the next interview 3 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with intestinal stoma
Key inclusion criteria (8 listed)
- Having no mental handicap or perception problems and no communication difficulties
- No psychiatric disease
- 18 years old and over
- literate
- Capable of using a smartphone
Key exclusion criteria (4 listed)
- After agreeing to participate in the research, wanting to leave,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation of the nurse navigation programAdult patients with intestinal stoma were contacted continuously for 6 months. | Behavioural | deney grubu |
Primary outcome
stoma compliance
Time frame: 6 month
stoma compliance scale
1 secondary outcome
life quality
Time frame: 6 month
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 Apr 2023.
- Derived from this study: PubMed 42399788Yurdagul G, Tosun N. Examining the effect of nurse navigation programme on stoma adjustment, quality of life, and prevention of complications in patients with stoma: a randomized controlled trial. BMC Gastroenterol. 2026 Jul 3. doi: 10.1186/s12876-026-05073-0. Online ahead of print.
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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.
nuran tosun, prof study director
nuran.tosun@hku.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Cancer, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
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 8 inclusion and 4 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
stoma compliance (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809661, which also lists 1 linked publication.
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 Apr 2023.