Colorectal CancerNCT05940740
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
A study testing Colorectal-Mobile application in people with Colorectal Cancer and Mobile Phone Use, run by NESLISAH YASAR KARTAL at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer, Mobile Phone Use, Nurse's Role
- What is being tested?
- Colorectal-Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not diagnosed with colorectal cancer
- Not diagnosed adjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beykent University
Istanbul, Buyukcekmece, 34528
About this study
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.
Read the 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
- Being tested
- Colorectal-Mobile application
- Keywords
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal-Mobile applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERFERENCE (EXPERIMENT) | Experimental | 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 Receives: Other: Colorectal-Mobile application |
| CONTROL | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: Two weeks
Secondary outcomes (1)
Self-Care Needs Evaluation Form
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".
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLISAH YASAR KARTAL
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Sponsor-investigator, NESLISAH YASAR KARTAL, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940740
- Sponsor's protocol ID
- 2022.10.13-34
- Status last verified
- Jul 2025
- First submitted
- 14 Apr 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05940740
- Acronym / sponsor ID
- 2022.10.13-34
- Conditions
- Colorectal Cancer, Mobile Phone Use, Nurse's Role
- Keywords
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NESLISAH YASAR KARTALUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERFERENCE (EXPERIMENT) | Experimental | Other: Colorectal-Mobile application1. 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 intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not diagnosed with colorectal cancer
- Not diagnosed adjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal-Mobile applicationThe 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. | Other | INTERFERENCE (EXPERIMENT) |
Primary outcome
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.
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.
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".
1 secondary outcome
Self-Care Needs Evaluation Form
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal-Mobile application in people with Colorectal Cancer and Mobile Phone Use, run by NESLISAH YASAR KARTAL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Colorectal (time frame: Two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.