Colorectal Cancer Clinical Trial
Official title:
the Effect of the Interactive Nurse Support Program, Developed as a Mobile Application, on Patient Outcomes in Colorectal Cancer Patients Receiving Chemotherapy During the Covid-19 Process
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 28, 2024 |
Est. primary completion date | April 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Volunteering to participate in research - Be over 18 years old - Being diagnosed with stage 0.1,2 colorectal cancer - Ability to understand and speak Turkish - ECOG performance score of 0.1 or 2 - Being literate - Having a mobile phone with an Android processor and being able to use it effectively - First time receiving chemotherapy Exclusion Criteria: - Presence of a diagnosed psychiatric illness - Having received previous chemotherapy - Diagnosis of metastatic colorectal cancer - ECOG performance score of 3 and 4 - Simultaneous radiation therapy with chemotherapy - Visual, auditory, mental or neurological disability - Taking part in another research that will affect the research results |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Bilkent City Hospital | Ankara | Çankaya |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 Beser 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 | |
Primary | 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 Yildirim et al. (2011), and the Cronbach a 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 | |
Primary | Change of Multidimensional Scale of Perceived Social Support Scale score at baseline and one week later fisrt,second,third and forth chemothraphy. | 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'sa 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 | |
Primary | 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 |
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