Investigation of the Effect of Training on the Side Effects of Chemotherapy Given Via the Mobile Health Application on the Quality of Life in Colorectal Cancer Patients

NCT ID: NCT05940740

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-14

Brief Summary

The incidence of colorectal cancer ranks fourth worldwide after lung, prostate and breast cancers. Although chemotherapy has an important place in the treatment of colorectal cancers, it can cause side effects such as diarrhea and fatigue in patients. Cancer patients' ability to cope with treatment side effects can be benefited from technological developments. Studies have shown that mobile health applications reduce symptom experience and increase quality of life in patients with breast cancer and leukemia.

Detailed Description

The incidence of colorectal cancer ranks fourth worldwide after lung, prostate and breast cancers. Although chemotherapy has an important place in the treatment of colorectal cancers, it can cause side effects such as diarrhea and fatigue in patients. Cancer patients' ability to cope with treatment side effects can be benefited from technological developments. Studies have shown that mobile health applications reduce symptom experience and increase quality of life in patients with breast cancer and leukemia. This research was planned as a quasi-experimental study with a pre-test-post-test control group in order to examine the effects of the mobile health application developed according to the Self-Care Disability Theory and the training given for chemotherapy side effects on the quality of life of colorectal cancer patients. The sample of the study will consist of patients who underwent chemotherapy outpatient (23 intervention group and 23 control group) with the diagnosis of colorectal cancer in the Internal Medicine Medical Oncology outpatient clinic of Istanbul University-Cerrahpasa Cerrahpasa Medical Faculty. Simple random sampling method, which is one of the probabilistic sampling methods, will be used to determine the intervention and control groups. Data will be obtained (pre-test) with the Patient Information Form, the Self-Care Needs Assessment Form, the Nightingale Symptom Assessment Scale (N-SDS), and the Cancer Treatment Functional Assessment-Colorectal Scale (FACT-C). Training will be provided to the initiative group through the mobile health application. Symptom management and quality of life will be evaluated by using data collection tools after the 1st and 2nd cycles of chemotherapy in intervention group patients. A face-to-face meeting with the initiative group is planned every two weeks. Once a week, an message will be sent to the intervention group patients reminding them to use the mobile health application. Control group patients will continue to receive routine treatment and follow-up. A post-test will be applied to the intervention and control groups in the third month (12 weeks after the first interview). In this study, it is aimed to compare the effectiveness of routine treatment and care with the use of a mobile health application developed according to the Self-Care Insufficiency Theory, considering the developments in today's technology, and to evaluate the effects of the two methods on the control of symptoms that may occur due to chemotherapy side effects in colorectal cancer patients and their care needs.

Conditions

Colorectal Cancer; Mobile Phone Use; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

INTERFERENCE (EXPERIMENT)

1. Giving patients with colorectal cancer about 20-30 minutes of training during chemotherapy with the mobile health application and answering face-to-face questions about the use of mobile health application.

2. Sending a reminder message about the use of mobile health application via phone once a week. Answering the questions about the mobile health application and the training given during the chemotherapy application every two weeks / summarizing the training

Group Type: EXPERIMENTAL

Colorectal-Mobile application

Intervention Type: OTHER

The use of Colorectal-Mobile application by the patients on a daily basis by the researcher will be monitored remotely via the management platform of the usage status of the mobile health application.

CONTROL

1. Giving approximately 20-30 minutes of routine treatment and care and answering questions during premedication application to colorectal cancer patients when they come to the unit to receive 1st cure chemotherapy.

2. Pre-test-post-test at the beginning of the 1st course of treatment and at the end of the 3rd cycle of treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colorectal-Mobile application

The use of Colorectal-Mobile application by the patients on a daily basis by the researcher will be monitored remotely via the management platform of the usage status of the mobile health application.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chemotherapy was started with the diagnosis of colorectal cancer,
• Receiving adjuvant chemotherapy,
• His psychological and general condition is suitable for the interview and
• Identified as colorectal cancer patients who volunteered to participate in the study

Exclusion Criteria

• Not diagnosed with colorectal cancer
• Not diagnosed adjuvant chemotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: collaborator

NESLISAH YASAR KARTAL

OTHER

Sponsor Role: lead

Responsible Party

NESLISAH YASAR KARTAL

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beykent University

Istanbul, Buyukcekmece, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022.10.13-34

Identifier Type: -

Identifier Source: org_study_id