Nursing Care for Gastrointestinal Cancer PatientsNCT05692284
The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients
A study testing routine care group and Care in accordance with Orem's theory group in people with Nursing Care for Gastrointestinal Cancer Patients, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Care for Gastrointestinal Cancer Patients
- What is being tested?
- routine care group and Care in accordance with Orem's theory group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 30 May 2023
- Phase
- Interventional
- 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
Who may be able to join
- Being literate
- Being diagnosed with gastrointestinal cancer
- Being receiving chemotherapy treatment and having information about the disease
- Getting a score of 120 or less in the Self-Care Strength Scale pre-test.
- Not having a physical illness or cognitive disability that prevents participation in the -research and not having a psychiatric illness diagnosis
- Having an Android phone and the ability to use it
- Not having sensory loss related to vision and hearing
- Being open to communication and cooperation
Who cannot join
- Patients who did not meet the inclusion criteria and were not volunteers were not included in the sample;
- Asking to leave the study
- Worsening of general condition/Death
- Change of treatment protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University
Erzurum, Yakutiye, (545) 743-1007
About this study
Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients\' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs.
Read the detailed description
Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients\' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs. The aim of this project is to evaluate the effects of self-care deficit care model and mobile application-supported care on symptoms and quality of life of patients with gastrointestinal cancer.
Material and method: The research was conducted as a experimental study. The universe of the research; Between Feb 2022 and Jan 2023, individuals who met the criteria for inclusion in the study who applied for home care to Erzurum Atatürk University Research Hospital Oncology Clinic with the diagnosis of gastrointestinal cancer. The sample size for the research was determined by power analysis. In the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p\<0.05 significance level. Considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. The patients included in the study were determined as intervention (n=30) and control (n=30). During the data collection process, 4 patients, 1 in the control group and 3 in the experimental group, died and the study was completed with the results of 29 control and 27 intervention group patients. "Patient Description Form" from the intervention and control group to determine the current physical and psychological self-care needs of patients with gastrointestinal cancer, "Edmonton Symptom Assesment Scale" physical symptoms experienced by patients, and "Quality of Life Scale" for psychological symptoms and the "Self care ability scale" for self care ability was used to collect information. Permissions for use were obtained for each of the scales. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
In the intervention group, symptoms on the ESAS improved significantly. The EORTC QLQC30 functionality and symptom sub-dimensions improved significantly. In the control group, the severity of symptoms increased and quality of life decreased compared to baseline measurements. While self-care competence increased significantly in the experimental group, there was no change in the control group. The need to develop \"common language, common care\" practices in oncology clinics, accompanied by an evidence-based guide, is also a priority in patient care. The results of this study showed that mobile app-supported Orem's care can effective on patients\' symptoms, and self care ability.
- Being tested
- routine care group, Care in accordance with Orem's theory group
- Keywords
- nursing care, mobil application, Orem's theory, self care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine care groupOther
Firstly, informed consent was obtained from the patients in the control group, a pre-test was applied with the existing data collection methods, and routine nursing care continued. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application.
Care in accordance with Orem's theory groupOther
Firstly, informed consent was obtained from the Intervention group, for which the pre-test was applied, and then care was given during their stay in the hospital in accordance with Orem's theory. This care was performed when the patient came to each chemotherapy cycle. After discharge, patient follow-up and care continued with the mobile application designed with Orem's theory, which will ensure the continuity of this care given in the clinic. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application.
| Study group | Role | What they receive |
|---|---|---|
| routine care group | Other | Routine clinic nursing care in hospital, no follow-up after discharge. Receives: Other: routine care group |
| Care in accordance with Orem's theory group | Experimental | care in accordance with Orem's theory in the hospital process and follow-up with a mobile application designed according to Orem's theory after discharge Receives: Other: Care in accordance with Orem's theory group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
Personal information form prepared by the researcher in line with the relevant literature; It consists of 20 questions that include socio-demographic characteristics such as age, gender, social security, educational status, disease-related features such as drugs used and duration of the disease.
Measured: 6 weeks
Secondary outcomes (3)
Edmonton Symptom Assesment Scale (ESAS)
ESAS was developed to evaluate nine common symptoms in cancer patients. These symptoms are; pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being, shortness of breath and other problems. The severity of each symptom is assessed by numerical numbers from 0 to 10. A score of 0 indicates that there is no symptom, and a score of 10 indicates that the symptom is felt very severely, and the severity of the symptom increases from 0 to 10.
Measured: 6 weeks
EORTC QLQC30 Quality of Life Scale
The EORTC-QLQ-C30 Quality of Life Scale is a scale developed by EORTC and includes three sub-headings of general well-being, functional difficulties, symptom control, and 30 questions. None: 1, Slightly: 2, Quite: 3, or A lot: 4 points.
Measured: 6 weeks
SELF CARE ABILITY SCALE
The Self-Care Ability Scale is used to determine the ability of individuals to take care of themselves. A high total score from the Self-Care Scale indicates that the patients are independent and sufficient in performing their self-care. There are 35 statements in the Turkish form and each statement is evaluated with scores ranging from 0 to 4. They are listed as 0 (does not describe me at all), 1 (does not describe me very well), 2 (no idea), 3 (describes me a little), 4 (describes me a lot). Eight statements in the scale (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and scoring is reversed. Evaluation is made out of a total of 140 points. Below 82 points is considered as low, 82-120 points as medium, above 120 points as high.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start2 Feb 2022
- Primary completion30 Jan 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing Care for Gastrointestinal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ciraci Yasar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692284
- Sponsor's protocol ID
- AtaturkU-NRS-YCY-01
- Status last verified
- Sep 2024
- First submitted
- 11 Jan 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients
- ClinicalTrials.gov ID
- NCT05692284
- Acronym / sponsor ID
- AtaturkU-NRS-YCY-01
- Keywords
- nursing care, mobil application, Orem's theory, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 20 Jan 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.
Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients\' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs.
Detailed description
Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients\' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs. The aim of this project is to evaluate the effects of self-care deficit care model and mobile application-supported care on symptoms and quality of life of patients with gastrointestinal cancer.
Material and method: The research was conducted as a experimental study. The universe of the research; Between Feb 2022 and Jan 2023, individuals who met the criteria for inclusion in the study who applied for home care to Erzurum Atatürk University Research Hospital Oncology Clinic with the diagnosis of gastrointestinal cancer. The sample size for the research was determined by power analysis. In the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p\<0.05 significance level. Considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. The patients included in the study were determined as intervention (n=30) and control (n=30). During the data collection process, 4 patients, 1 in the control group and 3 in the experimental group, died and the study was completed with the results of 29 control and 27 intervention group patients. "Patient Description Form" from the intervention and control group to determine the current physical and psychological self-care needs of patients with gastrointestinal cancer, "Edmonton Symptom Assesment Scale" physical symptoms experienced by patients, and "Quality of Life Scale" for psychological symptoms and the "Self care ability scale" for self care ability was used to collect information. Permissions for use were obtained for each of the scales. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
In the intervention group, symptoms on the ESAS improved significantly. The EORTC QLQC30 functionality and symptom sub-dimensions improved significantly. In the control group, the severity of symptoms increased and quality of life decreased compared to baseline measurements. While self-care competence increased significantly in the experimental group, there was no change in the control group. The need to develop \"common language, common care\" practices in oncology clinics, accompanied by an evidence-based guide, is also a priority in patient care. The results of this study showed that mobile app-supported Orem's care can effective on patients\' symptoms, and self care ability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
| Arm | Type | Receives |
|---|---|---|
| routine care group | Other | Other: routine care groupRoutine clinic nursing care in hospital, no follow-up after discharge. |
| Care in accordance with Orem's theory group | Experimental | Other: Care in accordance with Orem's theory groupcare in accordance with Orem's theory in the hospital process and follow-up with a mobile application designed according to Orem's theory after discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being literate
- Being diagnosed with gastrointestinal cancer
- Being receiving chemotherapy treatment and having information about the disease
- Getting a score of 120 or less in the Self-Care Strength Scale pre-test.
- Not having a physical illness or cognitive disability that prevents participation in the -research and not having a psychiatric illness diagnosis
Key exclusion criteria (4 listed)
- Patients who did not meet the inclusion criteria and were not volunteers were not included in the sample;
- Asking to leave the study
- Worsening of general condition/Death
- Change of treatment protocol
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 |
|---|---|---|
| routine care groupFirstly, informed consent was obtained from the patients in the control group, a pre-test was applied with the existing data collection methods, and routine nursing care continued. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application. | Other | routine care group |
| Care in accordance with Orem's theory groupFirstly, informed consent was obtained from the Intervention group, for which the pre-test was applied, and then care was given during their stay in the hospital in accordance with Orem's theory. This care was performed when the patient came to each chemotherapy cycle. After discharge, patient follow-up and care continued with the mobile application designed with Orem's theory, which will ensure the continuity of this care given in the clinic. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application. | Other | Care in accordance with Orem's theory group |
Primary outcome
Patient Identification Form
Time frame: 6 weeks
Personal information form prepared by the researcher in line with the relevant literature; It consists of 20 questions that include socio-demographic characteristics such as age, gender, social security, educational status, disease-related features such as drugs used and duration of the disease.
3 secondary outcomes
Edmonton Symptom Assesment Scale (ESAS)
Time frame: 6 weeks
EORTC QLQC30 Quality of Life Scale
Time frame: 6 weeks
SELF CARE ABILITY SCALE
Time frame: 6 weeks
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 27 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine care group and Care in accordance with Orem's theory group in people with Nursing Care for Gastrointestinal Cancer Patients, run by Ataturk 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 27 Sep 2024. 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?
Patient Identification Form (time frame: 6 weeks). 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 27 Sep 2024.