Trial Title:
The Effect of a Mobile Application on Patient Outcomes in Colorectal Cancer Patients
NCT ID:
NCT05813028
Condition:
Colorectal Cancer
Nursing
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
mobile application
Colorectal Cancer
nursing
symptom management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
a Mobile Application
Description:
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.
Arm group label:
experimental group
Other name:
KRK-İnHed
Summary:
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.
Detailed description:
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
1. Personal Information Form
2. Memorial Symptom Assessment Scale (MSDS)
3. EORTC QLQ-C30 and CR29 Quality of Life Scale
4. Multidimensional Scale of Perceived Social Support (MSPSS)
5. ECOG Performance Scale
6. Beck Anxiety Scale
7. Mobile Application Evaluation Form
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:
- COVID 19 Information Module
- Learning Module
- Discussion Module
- Ask the Expert Module
- Lived Stories Module
Part 2: Implementation of Mobile Application and Collection of Data
- Patients with colorectal cancer who apply to the Department of Medical Oncology will
be identified.
- Patients with colorectal cancer who meet the inclusion criteria will be determined
(ECOG Performance Scale will be applied at this stage).
- At the beginning of the study, patients who are planned to be included in the study
will be informed verbally and in writing about the study and it will be ensured that
Informed Consent Forms are filled and signed according to their acceptance status.
- The first day of chemotherapy will be determined for patients who meet the criteria
for inclusion in the study and accept to participate in the study. An appointment
will be made one day before the chemotherapy treatment and data collection forms
will be applied (day 0).
Applications for the Patients in the Experimental Group:
- Interviewing the patients in the experimental group the day before the start of
chemotherapy (day 0); Personal Information Form, Multidimensional Perceived Social
Support Scale, Quality of Life Scale, Beck Anxiety Scale will be filled.
- The mobile application will be installed on the patient's phone by the researcher.
The patient will be registered to the program by creating a changeable 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 during 4 cycles of
chemotherapy (1 cycle/3 weeks) from the first day of chemotherapy treatment.
- The patient will record the symptoms appearing since the first chemotherapy
treatment (symptom type, frequency and severity) in the mobile application, and
watch the relevant video recording according to the symptom experienced from the
symptom management videos. The patient will be informed that he can record more than
one symptom and watch all the videos as many times as he wants. Information texts on
patient colorectal cancer and coronavirus will also be accessible at any time. This
section covers the "Learning Module" of the mobile application.
- In addition to the video recording, which includes the management initiatives
related to the symptom experienced by the patient, the patient will convey his/her
individual questions to the researcher by text message or phone call, according to
his/her preference. According to the method of conveying the patient's question, the
patient's question will be answered by the researcher with the same method. As soon
as written messages are sent, they will appear on the researcher's phone screen and
the patient will be answered within 1 hour at the latest. If necessary according to
the content of the questions regarding the treatment, care or symptom management
submitted by the patient, the questions will be directed by the researcher to the
oncology physician, who is the other manager in the Ask the Specialist module. The
response from the physician will be communicated to the patient. This section covers
the "Ask an Expert Module" of the mobile application.
- A reminder message will be sent to the patients who do not register their symptoms
and log in to the system during the day, as of 20:00.
- Patients will be able to enter the Discussion Module according to their preferences
and share their experiences and opinions with other patients in the control group
who had the same experiences. This section covers the "Discussion Module" of the
mobile application.
- Patients will be able to watch video recordings containing interviews with patients
who have had the same experience and have come to the end of their treatment,
whenever they want and as many times as they want. This section covers the "Lived
Stories Module" of the mobile application.
- 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
the 2nd course of chemotherapy (week 6). Patients will use the mobile application
for 6 more weeks after receiving the second chemotherapy course. Within these 6
weeks, they will have received the 2nd course of chemotherapy in the 3rd week. 3.
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 re-administered when they come to the hospital for a course of chemotherapy
(Week 6). In the second 6 weeks (week 9), patients will have received their 4th
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 at the 12th week, the use of the mobile application will be
terminated and 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 and Mobile Application Effectiveness Evaluation Form (Appendix 8) will
be applied.
Applications for the Patients in the Control Group:
- Patients in the control group who will not have mobile applications installed on
their phones will receive standard care.
- The following forms will be filled in by interviewing the patients in the control
group the day before chemotherapy starts (day 0).
- Personal Information Form
- Multidimensional Scale of Perceived Social Support
- EORTC QLQ-C30 Quality of Life Scale and QLQ-CR29 Module
- Beck Anxiety Scale
- When the patients come to the outpatient clinic to receive their 3rd course of
chemotherapy (week 6), the Memorial Symptom Assessment Scale, Social Support Scale,
Quality of Life Scale and Anxiety Scale will be administered to the patients.
- When the patients come to the outpatient clinic (week 12), the Memorial Symptom
Rating Scale, Social Support Scale, EORTC QLQ-C30 Quality of Life Scale and QLQ-CR29
Module and Anxiety Scale will be re-administered to the patients.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
doğan uncu, professor
Phone:
+90 505 293 32 34
Email:
doganuncu@yahoo.com
Start date:
July 15, 2022
Completion date:
April 28, 2024
Lead sponsor:
Agency:
Ankara University
Agency class:
Other
Source:
Ankara University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05813028
