The Effect of a Mobile Application on Patient Outcomes in Colorectal Cancer Patients

NCT05813028 | Recruiting

• 1 other identifier: Burcu24ankara
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Nursing

Keywords

mobile application; Colorectal Cancer; nursing; symptom management

Outcome Measures

Primary Outcomes (4)

• 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.

  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

Study Arms (2)

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.

Other: a Mobile Application

control group

NO INTERVENTION

Patients in the control group who will not have a mobile application installed on their phones will receive standard care.

Interventions

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.

Also known as: KRK-İnHed

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• doğan uncu, professor

  ankara bilkent central hospital

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: April 14, 2023
• Study Start: July 15, 2022
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)