Colorektal CancerSelf ManagemetNCT07851675
Self-Management of Colon and Rectal Cancer Patients Receiving Oral Chemotherapy
A study testing Messaging Intervention Effectiveness in people with Colorektal Cancer, run by Ozlem at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to evaluate the effectiveness of a message-based intervention on self-management among patients with colorectal cancer receiving oral chemotherapy treatment. H1. Message intervention is effective in the self-management of colon and rheum cancer patients receiving oral chemotherapy. H2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorektal Cancer
- What is being tested?
- Messaging Intervention Effectiveness
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 30 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate and able to speak Turkish Diagnosed with colon or rectal cancer (either newly diagnosed or previously diagnosed) and aware of their diagnosis Able to use a telephone and reachable by phone Newly starting oral chemotherapy treatment At any stage of treatment (patients receiving additional IV chemotherapy and/or radiotherapy alongside oral chemotherapy will also be included) Diagnosed with cancer at any stage (Stage I-IV) Aged 21 years or older
Who cannot join
- Patients who cannot be contacted by phone
- Patients with an ECOG performance status of 4 or higher Patients with hearing or vision impairments Illiterate patients Patients who cannot use a smartphone Patients diagnosed with psychiatric disorders requiring medication or hospitalization Patients who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effectiveness of Message Intervention in Self-Management of Colon and Rectal Cancer Patients Receiving Oral Chemotherapy
Objective: This study aims to evaluate the effectiveness of a message-based intervention on self-management among patients with colorectal cancer receiving oral chemotherapy treatment.
H1. Message intervention is effective in the self-management of colon and rheum cancer patients receiving oral chemotherapy.
Read more
H2. Message intervention is not effective in the self-management of colon and rheum cancer patients receiving oral chemotherapy.
Methods: This is a longitudinal, randomized controlled experimental study to be conducted at Dokuz Eylul University Hospital over a 10-week follow-up period. A total of 40 patients (20 in each group) will be included, with randomization based on age, educational level, and treatment protocol. Data will be collected using the Personal Information Form, Medication Adherence Self-Efficacy Scale (MASES), Edmonton Symptom Assessment Scale, the Short Message Evaluation Questionnaire, and the Patient Satisfaction Scale. Interviews will be conducted at baseline, on the 7th day of medication use, and during the 2nd, 6th, and 9th weeks.
Results and Conclusion: Data will be analyzed using SPSS version 15.0. Descriptive statistics, chi-square tests, t-tests, Cochrane Q test, repeated measures ANOVA, and regression analysis will be employed. Effect size will be calculated using Cohen's d, and the significance level will be set at p < 0.05.
Read the detailed description
Setting and Participants The study will be conducted in the Day Treatment Center and Medical Oncology Outpatient Clinic at Dokuz Eylul University Hospital. The population consists of patients diagnosed with colon or rectum cancer who are newly starting oral chemotherapy, aged 21 years or older, literate in Turkish, and able to use a mobile phone. Patients with an ECOG performance score ≥4, severe visual/hearing impairments, psychiatric illness requiring medication, illiteracy, or inability to use a smartphone will be excluded.
Intervention The intervention group will receive a structured, web-based messaging program aimed at supporting medication adherence and symptom management in addition to routine care. This includes weekly symptom monitoring and medication reminders, along with nursing interventions such as education, self-care guidance, and counseling based on reported symptoms. The control group will receive routine care and an informational booklet only.
Follow-Up and Data Collection Follow-up will last 10 weeks, with face-to-face assessments conducted at baseline and at pre-specified time points. Data will be collected using validated instruments to measure adherence, symptom severity, and patient satisfaction, alongside a custom short message evaluation form. Non-adherence will be defined as not using the web-based system, reporting increased symptom severity, or deviation from the prescribed medication regimen.
- Conditions
- Colorektal Cancer
- Being tested
- Messaging Intervention Effectiveness, control group
- Keywords
- Mobile health (mHealth), Supportive care, Self-management, Oral Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messaging Intervention EffectivenessOther
The intervention involved sending weekly mobile messages to participants, providing medication reminders, motivational support, and symptom management tips, aiming to improve medication adherence and reduce symptom burden.Additionally, the control group will receive an educational manual from the start of the study.
control groupOther
Participants in the control group received only standard care without any additional mobile messaging or intervention.Additionally, the control group will receive an educational manual from the start of the study.
| Study group | Role | What they receive |
|---|---|---|
| A structured web-based protocol was designed specifically for patients in the intervention group | Experimental | Patient Enrollment (Week 1):
Explanation of the web-based method
Provision of symptom management education and booklet
Study procedure overview
Web-Based Response System (Weeks 2-8):
Recording the number of pills taken by the participant within the last 7 days
Questionnaires:
Personal Information Form (at patient enrollment)
Medication Adherence Self-Efficacy Scale (MASES) (administered at patient enrollment; on the 7th day of medication use; during face-to-face interviews in the 3rd, 6th, and 9th weeks; and during the 15-day follow-up after study completion)
Edmonton Symptom Assessment System (administered at patient enrollment; on the 7th day of medication use; during face-to-face interviews in the 3rd, 6th, and 9th weeks; and during the 15-day follow-up after study completion)
Short Message Effectiveness Evaluation Questionnaire (administered at the end of the study)
Patient Satisfaction Scale (administered at the end of the study) Receives: Other: Messaging Intervention Effectiveness |
| Control group | Other | Participants in the control group received routine standard care provided by their physician. In general, patients are informed about oral chemotherapy agents, including information regarding the medication itself, dosage, potential side effects, symptom management strategies, and guidance on addressing any questions related to their treatment.Additionally, the control group will receive an educational manual from the start of the study. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Over Time in Medication Adherence Self-Efficacy Scale (MASES) Score
Medication adherence self-efficacy was assessed using the 24-item Medication Adherence Self-Efficacy Scale (MASES). Each item is scored from 1 to 3. The participant-level scale score is calculated as the mean of the 24 item scores and ranges from 1 to 3, with higher scores indicating greater medication adherence self-efficacy. Repeated scores were used to assess the pattern of change over time. Day 7 was the first assessment after initiation of the intervention and was not a pre-intervention baseline.
Measured: Day 7, Week 3, and Week 9 after enrollment
Secondary outcomes (2)
Change Over Time in an Eight-Item ESAS-Based Total Symptom Burden Score
Symptom burden was assessed using a study-specific eight-item total score derived from the Edmonton Symptom Assessment System (ESAS). The included items were pain, fatigue, nausea, sadness, anxiety, sleep problems, loss of appetite, and poor well-being. Each item is rated from 0 to 10, with higher scores indicating worse symptoms. The eight item scores are summed to produce one total score ranging from 0 to 80; higher total scores indicate greater symptom burden. Repeated total scores were used to assess change over time. This outcome represents a single composite symptom burden score, not separate measures of symptom frequency and severity.
Measured: Day 1, Day 7, and weekly at Weeks 2 through 10 after enrollment.
Percentage of Participants Reporting That SMS Messages Were Mostly Helpful
Perceived helpfulness of SMS messages was assessed in the intervention group using the researcher-developed SMS Effect Evaluation Form. The outcome is the percentage of respondents who selected the response category indicating that the messages were mostly helpful.
Measured: Week 10 after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start30 May 2024
- Primary completion30 May 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorektal 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the intervention group will be monitored according to a protocol developed by the researcher. Face-to-face interviews will be conducted by an experienced interviewer at four different times: on day 7 of oral chemotherapy and at weeks 2, 6, and 9. The purpose of these interviews is to collect information on medication adherence, current health status, and symptoms. During the initial interview, patients will be provided with detailed information about the operation of the web-based system. This information includes how to complete weekly forms, report symptoms, and submit questions through the platform. As part of the intervention, a web-based monitoring protocol has been developed for use over a 21-day period (14 days with system support and 7 days without). During this period, patients will be asked to respond to weekly symptom messages and enter medication usage data into the system. Patients will be excluded from the study if the system is not used regularly, medication
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozlem
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Sponsor-investigator, Ozlem, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851675
- Sponsor's protocol ID
- 2023/16-13
- Acronym
- Self Managemet
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Apart from the patients' personal data, the study method, data collection process, outgoing message content and results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Message Intervention in Self-Management of Colon and Rectal Cancer Patients Receiving Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT07851675
- Acronym / sponsor ID
- Self Managemet / 2023/16-13
- Conditions
- Colorektal Cancer
- Keywords
- Mobile health (mHealth), Supportive care, Self-management, Oral Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- OzlemUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 1 Oct 2026 (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.
Objective: This study aims to evaluate the effectiveness of a message-based intervention on self-management among patients with colorectal cancer receiving oral chemotherapy treatment.
H1. Message intervention is effective in the self-management of colon and rheum cancer patients receiving oral chemotherapy.
H2. Message intervention is not effective in the self-management of colon and rheum cancer patients receiving oral chemotherapy.
Methods: This is a longitudinal, randomized controlled experimental study to be conducted at Dokuz Eylul University Hospital over a 10-week follow-up period. A total of 40 patients (20 in each group) will be included, with randomization based on age, educational level, and treatment protocol. Data will be collected using the Personal Information Form, Medication Adherence Self-Efficacy Scale (MASES), Edmonton Symptom Assessment Scale, the Short Message Evaluation Questionnaire, and the Patient Satisfaction Scale. Interviews will be conducted at baseline, on the 7th day of medication use, and during the 2nd, 6th, and 9th weeks.
Results and Conclusion: Data will be analyzed using SPSS version 15.0. Descriptive statistics, chi-square tests, t-tests, Cochrane Q test, repeated measures ANOVA, and regression analysis will be employed. Effect size will be calculated using Cohen's d, and the significance level will be set at p < 0.05.
Detailed description
Setting and Participants The study will be conducted in the Day Treatment Center and Medical Oncology Outpatient Clinic at Dokuz Eylul University Hospital. The population consists of patients diagnosed with colon or rectum cancer who are newly starting oral chemotherapy, aged 21 years or older, literate in Turkish, and able to use a mobile phone. Patients with an ECOG performance score ≥4, severe visual/hearing impairments, psychiatric illness requiring medication, illiteracy, or inability to use a smartphone will be excluded.
Intervention The intervention group will receive a structured, web-based messaging program aimed at supporting medication adherence and symptom management in addition to routine care. This includes weekly symptom monitoring and medication reminders, along with nursing interventions such as education, self-care guidance, and counseling based on reported symptoms. The control group will receive routine care and an informational booklet only.
Follow-Up and Data Collection Follow-up will last 10 weeks, with face-to-face assessments conducted at baseline and at pre-specified time points. Data will be collected using validated instruments to measure adherence, symptom severity, and patient satisfaction, alongside a custom short message evaluation form. Non-adherence will be defined as not using the web-based system, reporting increased symptom severity, or deviation from the prescribed medication regimen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the intervention group will be monitored according to a protocol developed by the researcher. Face-to-face interviews will be conducted by an experienced interviewer at four different times: on day 7 of oral chemotherapy and at weeks 2, 6, and 9. The purpose of these interviews is to collect information on medication adherence, current health status, and symptoms. During the initial interview, patients will be provided with detailed information about the operation of the web-based system. This information includes how to complete weekly forms, report symptoms, and submit questions through the platform. As part of the intervention, a web-based monitoring protocol has been developed for use over a 21-day period (14 days with system support and 7 days without). During this period, patients will be asked to respond to weekly symptom messages and enter medication usage data into the system. Patients will be excluded from the study if the system is not used regularly, medication
| Arm | Type | Receives |
|---|---|---|
| A structured web-based protocol was designed specifically for patients in the intervention group | Experimental | Other: Messaging Intervention EffectivenessPatient Enrollment (Week 1): Explanation of the web-based method Provision of symptom management education and booklet Study procedure overview Web-Based Response System (Weeks 2-8): Recording the number of pills taken by the participant within the last 7 days Questionnaires: Personal Information Form (at patient enrollment) Medication Adherence Self-Efficacy Scale (MASES) (administered at patient enrollment; on the 7th day of medication use; during face-to-face interviews in the 3rd, 6th, and 9th weeks; and during the 15-day follow-up after study completion) Edmonton Symptom Assessment System (administered at patient enrollment; on the 7th day of medication use; during face-to-face interviews in the 3rd, 6th, and 9th weeks; and during the 15-day follow-up after study completion) Short Message Effectiveness Evaluation Questionnaire (administered at the end of the study) Patient Satisfaction Scale (administered at the end of the study) |
| Control group | Other | Other: control groupParticipants in the control group received routine standard care provided by their physician. In general, patients are informed about oral chemotherapy agents, including information regarding the medication itself, dosage, potential side effects, symptom management strategies, and guidance on addressing any questions related to their treatment.Additionally, the control group will receive an educational manual from the start of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Literate and able to speak Turkish Diagnosed with colon or rectal cancer (either newly diagnosed or previously diagnosed) and aware of their diagnosis Able to use a telephone and reachable by phone Newly starting oral chemotherapy treatment At any stage of treatment (patients receiving additional IV chemotherapy and/or radiotherapy alongside oral chemotherapy will also be included) Diagnosed with cancer at any stage (Stage I-IV) Aged 21 years or older
Key exclusion criteria (2 listed)
- Patients who cannot be contacted by phone
- Patients with an ECOG performance status of 4 or higher Patients with hearing or vision impairments Illiterate patients Patients who cannot use a smartphone Patients diagnosed with psychiatric disorders requiring medication or hospitalization Patients who do not consent to participate in the study
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 |
|---|---|---|
| Messaging Intervention EffectivenessThe intervention involved sending weekly mobile messages to participants, providing medication reminders, motivational support, and symptom management tips, aiming to improve medication adherence and reduce symptom burden.Additionally, the control group will receive an educational manual from the start of the study. | Other | A structured web-based protocol was designed specifically for patients in the intervention group |
| control groupParticipants in the control group received only standard care without any additional mobile messaging or intervention.Additionally, the control group will receive an educational manual from the start of the study. | Other | Control group |
Primary outcome
Change Over Time in Medication Adherence Self-Efficacy Scale (MASES) Score
Time frame: Day 7, Week 3, and Week 9 after enrollment
Medication adherence self-efficacy was assessed using the 24-item Medication Adherence Self-Efficacy Scale (MASES). Each item is scored from 1 to 3. The participant-level scale score is calculated as the mean of the 24 item scores and ranges from 1 to 3, with higher scores indicating greater medication adherence self-efficacy. Repeated scores were used to assess the pattern of change over time. Day 7 was the first assessment after initiation of the intervention and was not a pre-intervention baseline.
2 secondary outcomes
Change Over Time in an Eight-Item ESAS-Based Total Symptom Burden Score
Time frame: Day 1, Day 7, and weekly at Weeks 2 through 10 after enrollment.
Percentage of Participants Reporting That SMS Messages Were Mostly Helpful
Time frame: Week 10 after enrollment.
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Apart from the patients' personal data, the study method, data collection process, outgoing message content and results will be shared.
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 Messaging Intervention Effectiveness in people with Colorektal Cancer, run by Ozlem 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 1 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 21 Oct 2026. 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?
Change Over Time in Medication Adherence Self-Efficacy Scale (MASES) Score (time frame: Day 7, Week 3, and Week 9 after enrollment). 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 21 Oct 2026.