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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2025
CompletedJuly 14, 2025
July 1, 2025
1 year
April 14, 2023
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional Assessment of Cancer Therapy-Colorectal
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
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
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 Outcomes (1)
Self-Care Needs Evaluation Form
Two weeks
Study Arms (2)
INTERFERENCE (EXPERIMENT)
EXPERIMENTAL1. 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
CONTROL
NO INTERVENTION1. 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not diagnosed with colorectal cancer
- Not diagnosed adjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NESLISAH YASAR KARTALlead
- Saglik Bilimleri Universitesicollaborator
Study Sites (1)
Beykent University
Istanbul, Buyukcekmece, 34528, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
April 14, 2023
First Posted
July 11, 2023
Study Start
March 1, 2023
Primary Completion
March 1, 2024
Study Completion
January 14, 2025
Last Updated
July 14, 2025
Record last verified: 2025-07