Self-Management of Colon and Rectal Cancer Patients Receiving Oral Chemotherapy

NCT07851675 | Completed

• 1 other identifier: 2023/16-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorektal Cancer

Keywords

Mobile health (mHealth); Supportive care; Self-management; Oral Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 1, Day 7, and weekly at Weeks 2 through 10 after enrollment.

• Percentage of Participants Reporting That SMS Messages Were Mostly Helpful

  Week 10 after enrollment.

Other Outcomes (3)

• Satisfaction With Telephone Counseling

  Week 10 after enrollment, at the end of follow-up.

• Intervention Compliance (System Usage)

  Weeks 2-9.

• Percentage of Participants Reporting Problems With the SMS System

  Week 10 after enrollment.

Study Arms (2)

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)

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.

Other: control group

Interventions

Messaging Intervention Effectiveness OTHER

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.

A structured web-based protocol was designed specifically for patients in the intervention group

control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ozlem: lead
• Dokuz Eylul University: collaborator

Study Sites (1)

Dokuz Eylül Üniversitesi

Konak, İzmir, 35250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr

Model Details: 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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: October 1, 2026
• Study Start: May 30, 2024
• Primary Completion: May 30, 2026
• Study Completion: August 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The de-identified dataset and supporting documents will be available within 6 months after publication of the primary results and will remain accessible for 5 years thereafter.
• Access Criteria: Data will be made available to qualified researchers affiliated with recognized academic or research institutions, upon submission of a data access request outlining the research objectives and analysis plan. Requests will be reviewed by the principal investigator, and access will be granted through a secure data-sharing platform.

Locations

TU (1)