- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512726
DevelopmentA Web-Based Support Care Program for Individuals Diagnosed With Colorectal Cancer
Development And Evaluation of The Effectiveness of A Web-Based Support Care Program for Individuals Diagnosed With Colorectal Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34840
- Koc University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of colon cancer and receiving cancer treatment (within the first 3 months of diagnosis)
- Being 18 years of age or older
- Being able to read, understand, and communicate in Turkish
- Having internet access
- Being able to use a smartphone or computer
- Having access to a smartphone or computer
- Voluntary participation in the study
Exclusion Criteria:
- Having a psychiatric illness
- Having a disability that impairs cognitive functions
- Refusing to participate in the study
- Poor general health
- Incompatibility between treatment appointments and the study's data collection schedule
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Patients in the control group received standard treatment and care at the hospital where they were followed up. Initial interviews with patients were conducted in person. After obtaining verbal and written consent from patients who volunteered to participate in the study, the "Edmonton Symptom Assessment Scale" and the "Functional Assessment in Cancer Treatment-Colorectal Cancer Scale" were administered. The same scales were administered again via telephone one month (second follow-up) and three months (final follow-up) after the initial data collection. Institutional Standard Care: At the institution where the study was conducted, patients receiving chemotherapy were informed by their primary nurse about the medication protocol, drug-related side effects, and possible symptoms. They were also given educational brochures on topics such as pain, nausea, and precautions to take when using port needles. Nurses in the outpatient chemotherapy unit additionally planned the patients' treatm |
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Experimental: intervention group
Experimental Group Patients in the experimental group used the web-based "Meet in Health Support Care Program" for 3 months in addition to routine care. The initial interview with the patients was conducted face-to-face. Verbal and written consent was obtained from patients who volunteered to participate in the study. During the interview, the goal and content of the study were explained, the website was introduced, and information on its use was provided. In addition, the Edmonton Symptom Assessment Scale and the Functional Assessment in Cancer Treatment-Colorectal Cancer Scale were administered during the first interview. One month (second follow-up) and three months (final follow-up) after the collection of the initial data, the same scales were administered again by telephone interviews with the patients. In the final follow-up (3rd month), the "Website Usability Scale" was administered to the patients to evaluate their satisfaction with the support care program. |
This study developed a supportive care program for individuals diagnosed with colorectal cancer who are undergoing cancer treatment, focusing on the symptoms and quality of life experienced by patients during treatment. The sub-headings and content of the planned program were prepared within the framework of the "Supportive Care Framework," frequently used for cancer patients. This framework, comprising 7 main concepts (physical, emotional, social, psychosocial, spiritual/mental, informational, and practical-daily life changes), aims to provide a holistic approach to patients' needs. Furthermore, the program content includes the experiences of individuals who have gone through similar experiences and have recovered from cancer. All these approaches constitute the unique values of this study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Measured by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Scale
Time Frame: From enrollment to the end of treatment at 3 months
|
The Functional Assessment in Cancer Treatment-Colorectal Cancer Scale (FACT-C) was administered to evaluate the quality of life of patients undergoing chemotherapy.
The scale is part of the Functional Assessment in Chronic Disease Treatment (FACIT) measurement system and is used to assess common conditions seen in all cancer patients, as well as specific concerns associated with colorectal cancer.
|
From enrollment to the end of treatment at 3 months
|
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Symptom Severity Measured by the Edmonton Symptom Assessment Scale
Time Frame: From enrollment to the end of treatment at 3 months
|
The Edmonton Symptom Assessment Scale was used to evaluate the symptoms experienced by patients during chemotherapy treatment.
The scale assesses 10 symptoms: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, general malaise, shortness of breath, and other problems.
|
From enrollment to the end of treatment at 3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/11-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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