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

July 9, 2025 updated by: NESLISAH YASAR KARTAL
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Buyukcekmece
      • Istanbul, Buyukcekmece, Turkey, 34528
        • Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy-Colorectal
Time Frame: Two weeks

The Functional Assessment of Cancer Therapy-Colorectal Scale was first developed by Ward et al. in 1999 in the USA by the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System.

The scale consists of a total of 5 dimensions and a total of 46 items. The scale consists of Ordinary Physical Status sub-dimension, Social Life and Family Status sub-dimension, intense Status sub-dimension, Activity Status sub-dimension and Other Concerns sub-dimensions.

In the evaluation made with the FACT-C Scale, the subject is asked to answer each statement by observing the last 7th day indicator. Each item of the scale is evaluated on a 5-point Likert-type scale ("never" = 0, "very little" = 1, "some" = 2, "quite" = 3, "a lot" = 4). Its total score is between 0-136.
Two weeks
Patient Information Form
Time Frame: Two weeks
The Patient Information Form was prepared considering the factors that may affect the self-care of patients diagnosed with colorectal cancer who underwent outpatient chemotherapy within a year. This form consists of a total of 19 questions questioning the characteristics of the individual, the disease and the treatment.
Two weeks
Nightingale Symptom Evaluation Scale
Time Frame: Two weeks

The Nightingale Symptom Evaluation Scale (2009) was developed by Can and Aydıner for patients diagnosed with cancer. The scale includes three sub-dimensions. These sub-dimensions are "Physical Well-Being", "Social Well-Being" and "Psychological Well-Being".

The answers given by the patients to the scale are scored from 0 to 4 and answered on a five-point Likert type scale. Patients are asked to evaluate these questions by choosing one of the points "No" "0 points", "Very little" "1 point", "A little" "2 points", "Quite" "3 points", "Too much" "4 points".
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Care Needs Evaluation Form
Time Frame: Two weeks
There are 28 statements in the Self-Care Needs Evaluation Form, which include the self-care needs of patients with colorectal cancer. In this form, it will question the self-care needs of colorectal cancer patients in case of universal, developmental and health deviations. Patients are asked to answer these statements by choosing one of the options "Yes", "Sometimes" or "No".
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NESLISAH YASAR KARTAL

Collaborators

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

January 14, 2025

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.10.13-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe