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The aim of this study is to determine the effect of the interactive nurse support program developed as a mobile application on patient outcomes (symptom management, quality of life, perception of social support and anxiety) in colorectal cancer patients receiving chemotherapy during the COVID-19 process; It was planned in a randomized controlled, single-blind design. In the study, a mobile application will be designed for colorectal cancer patients with the content created in line with the literature. In the application, the "about COVID-19" module, which includes information for colorectal cancer patients during the COVID-19 process, the "learning module" in which the symptoms and suggestions for colorectal cancer patients receiving chemotherapy are included, the "discussion" module where patients can share their knowledge and experiences with each other, The "ask the expert" module, where nurses and physicians can ask questions, will be comprised of the "lived stories" module and the communication sections, which include interview videos made with individuals who are in remission only after completing the treatment related to the disease. A pretest consisting of Personal Information Form, Multidimensional Perceived Social Support Scale EORTC QLQ-C30 and CR29 Quality of Life Scale, ECOG Performance Scale and Beck Anxiety Scale will be administered to all patients included in the study. The mobile application will be installed on the phones of the patients in the experimental group and they will be used for 12 weeks. Patients in the control group will receive standard care during this process and no intervention will be made. In the sixth and twelve weeks, all participants will be given a posttest. The change in symptom management, quality of life, perceived social support and anxiety levels of the experimental group after mobile application use will be evaluated.
Type of Research:
The research was randomized controlled, analytically planned.
Research Hypotheses:
H0-1: The interactive nurse support program developed with the mobile application in colorectal cancer patients receiving chemotherapy during the COVID-19 process has no effect on the quality of life of the patients.
H0-2: The interactive nurse support program developed with the mobile application in colorectal cancer patients receiving chemotherapy during the COVID-19 process has no effect on the social support perceived by the patients.
H0-3: The interactive nurse support program developed with the mobile application in colorectal cancer patients receiving chemotherapy during the COVID-19 process has no effect on the anxiety levels of the patients.
H0-4: The interactive nurse support program developed with a mobile application has no effect on symptom management in colorectal cancer patients receiving chemotherapy during the COVID-19 process.
Population and Sample of the Research:
The population of the research will be the colorectal cancer patients followed in the Ankara City Hospital Medical Oncology Department Outpatient Clinics.
Calculating Sample Size When previous similar studies on sample size were examined, no similar research could be found in terms of sample characteristics and measurement tools. For this reason, after reaching 10 people in the intervention and control groups, the minimum number of people to be included in the sample will be calculated by performing a power analysis from the research results.
In order to determine the sample size, a similar study (Zhu et al. 2018) was examined, but it was seen that the measurement tools were different. For this reason, after reaching 10 people in the research and control group, power analysis will be made with the G. Power program and the minimum number of people to be sampled will be calculated. It is aimed to increase the number of samples in order to increase the power of the research by guaranteeing the minimum number of people that will constitute the sample size.
Randomization Method:
Among the patients who applied to Ankara City Hospital Medical Oncology Department Outpatient Clinics with the diagnosis of colorectal cancer to receive chemotherapy treatment, patients who meet the criteria for inclusion in the study will be determined. In order to prevent possible interaction between patients who meet the inclusion criteria of the study, data wiil be collected from the control group first, according to the order of admission to the hospital, and after the target number is reached, data will be collected from the patients in the intervention group.
Data Collection Forms
Pre-Application:
In order to evaluate the intelligibility and usability of the mobile application and data collection forms created for the interactive nurse support program, a preliminary application was made with 5 patients who met the criteria for inclusion in the study among the patients who applied to Ankara City Hospital Medical Oncology Department Outpatient Clinics with the diagnosis of Colorectal Cancer for chemotherapy treatment. will be done. After the preliminary application, necessary changes will be made in the mobile application and data collection forms. Patients included in the pre-application scope will not be included in the study sample.
Application of Research:
Part 1: Development of Mobile Application 1.1.Developing the Content of the Mobile Application The content of the mobile application will be created by the researcher as a result of extensive literature research. The content created will be submitted to expert opinion, including 1 oncologist, 1 surgical oncology specialist, 4 nurse lecturers, 1 psychiatrist, 1 psychologist, 1 Turkish linguist and 2 oncology nurses. At the same time, the content of the mobile application will be examined by 3 colorectal cancer patients and its comprehensibility will be evaluated. As a result of expert opinions and patient evaluations, arrangements will be made in the content of the mobile application and the mobile application will be finalized.
The content of the mobile application will consist of 5 parts:
Part 2: Implementation of Mobile Application and Collection of Data
Applications for the Patients in the Experimental Group:
Applications for the Patients in the Control Group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | As an intervention, the mobile application called KRK-İnHED will be installed on the patients' phones. Patients in the experimental group will be interviewed the day before chemotherapy starts. Personal Information Form, Multidimensional Perceived Social Support Scale, Quality of Life Scale, Beck Anxiety Scale will be filled in these patients. Mobile application will be installed on the patient's phone by the researcher. The patient will be registered to the program by creating a user name. The patient will be given 15-20 minutes of online training on the use of the mobile application. The mobile application will be applied for a total of 12 weeks for 4 cycles (1 cycle/3 weeks) from the first day of chemotherapy treatment. |
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| control group | No Intervention | Patients in the control group who will not have a mobile application installed on their phones will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a Mobile Application | Other | Patients will use the mobile application for 6 weeks after receiving the first course of chemotherapy. The Multidimensional Scale of Perceived Social Support, Memorial Symptom Rating Scale, EORTC QLQ-C30 Quality of Life Scale and QLQ-CR29 Module, Beck Anxiety Scale will be administered when they come to the hospital for their 2nd course of chemotherapy. Patients will use the mobile application for 6 more weeks after receiving the second chemotherapy course. 3. The scales will be reapplied when they come to the hospital for a chemotherapy course. Patients will continue to use the mobile application for three more weeks after receiving their 4th and final cure. When the patients come to the outpatient clinic control in the 12th week, the use of the mobile application will be terminated and the Mobile Application Efficiency Evaluation Form will be applied together with the other scales. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of EORTC QLQ-C30 Quality of Life Scale and QLQ- CR29 Module score at baseline and one week later fisrt,second,third and forth chemothraphy. | EORTC QLQ-C30 Version 3.0 Quality of Life Scale is a scale developed by EORTC and used in cancer patients. Content validity and reliability study was conducted in Turkey by Beşer and Öz, Cronbach's alpha coefficient was r= 0.9014. The first 28 of the 30 items in the scale are of four-point Likert type and the items are evaluated as Never: 1, A little bit: 2, Quitely: 3, A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale of 1 to 7 (1: very poor and 7: excellent), and in the 30th question, the patient's overall quality of life is asked. High functional scale and general health status scale scores of the patients; A low symptom scale score indicates a high quality of life. EORTC QLQ CR 29 is an adapted quality of life scale for colorectal cancer. All 29 items in the scale are in four-point Likert type and the items are evaluated as Never: 1, A little: 2, Quitely: 3, A lot: 4 points. | the first measure will be made before chemotherapy. The second, third,forth and fifth measurement will be madeone week after the first second, third and forth chemotherapy. respectively |
| Change of memorial symptom assesment Scale score at baseline and one week later fisrt,second,third and forth chemothraphy. | The Memorial Symptom Assessment Scale was developed by Portenoy et al. (1994). The validity and reliability of the scale were made by Yıldırım et al. (2011), and the Cronbach α coefficient was found to be 0.84. The scale has 32 items and allows to evaluate the frequency and severity of the symptoms experienced by cancer patients. While the 'frequency' and 'severity' levels of the symptoms are answered as a 4-point likert, the 'distress' levels are answered as a 5-point likert. The MSAS total score is obtained by averaging the 32 symptom scores. Each symptom score is calculated by averaging the frequency, severity, and degree of distress. Higher values indicate higher frequency, severity, and distress. | the first measure will be made before chemotherapy. The second, third,forth and fifth measurement will be madeone week after the first second, third and forth chemotherapy. respectively |
| Change of Multidimensional Scale of Perceived Social Support Scale score at baseline and one week later fisrt,second,third and forth chemothraphy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| burcu ağdemir, res. assis. | Contact | +90 531 402 62 56 | bagdemir@ankara.edu.tr | |
| ayten demir, professor | Contact | +90 532 549 79 27 | aytendemir@ankara.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| doğan uncu, professor | ankara bilkent central hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | Çankaya | 06800 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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The Multidimensional Scale of Perceived Social Support was developed by Zimet et al. (Zimet et al. 1988) and the Turkish validity and reliability of MSPSQ was performed by Eker et al. (Eker et al., 1995). The Multidimensional Scale of Perceived Social Support subjectively evaluates the adequacy of social support from three different sources. This scale is a scale consisting of 12 items. It includes 3 groups related to the source of the support, each of which consists of 4 items. These; family, friends and a special person. Each item was rated using a 7-point scale. In the group treated as a special person; Persons such as dating, relatives, neighbors, doctors and nurses are included. The Turkish reliability of the scale was found to be 0.88 Cronbach'sα coefficient. Any score between 12 and 84 can be obtained from the scale, and a high score indicates a high perceived social support. |
| the first measure will be made before chemotherapy. The second, third,forth and fifth measurement will be madeone week after the first second, third and forth chemotherapy. respectively |
| Change of Beck Anxiety Inventory score at baseline and one week later fisrt,second,third and forth chemothraphy. | Beck Anxiety Inventory is a 21-item self-assessment scale developed by Aeron T. Beck in 1988. Ulusoy et al. It was translated into Turkish and validated in 1998 by The items in the scale describe the subjective, somatic and panic symptoms of anxiety. All item scores are summed as "0=none, 1=mild, 2=moderate, 3=severe" for each item. The scale is evaluated over a total of 63 points, and a high score indicates a high level of anxiety. | the first measure will be made before chemotherapy. The second, third,forth and fifth measurement will be madeone week after the first second, third and forth chemotherapy. respectively |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |