Colorectal CancerNCT07512726
DevelopmentA Web-Based Support Care Program for Individuals Diagnosed With Colorectal Cancer
A study testing web based supportive care programme in people with Colorectal Cancer and Colorectal (Colon or Rectal) Cancer, run by Ilknur Yazicioglu at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to develop and evaluate the effectiveness of a web-based supportive care program for individuals diagnosed with colorectal cancer undergoing cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal (Colon or Rectal) Cancer
- What is being tested?
- web based supportive care programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2025to 30 Jan 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Istanbul, 34840
About this study
Official title: Development And Evaluation of The Effectiveness of A Web-Based Support Care Program for Individuals Diagnosed With Colorectal Cancer
This study was designed to develop and evaluate the effectiveness of a web-based supportive care program for individuals diagnosed with colorectal cancer undergoing cancer treatment. The program's effectiveness is evaluated based on the symptom burden and quality of life experienced by patients during cancer treatment. This randomized controlled trial was conducted with the participation of patients diagnosed with colorectal cancer receiving treatment at the Outpatient Chemotherapy Unit of Koç University Hospital. Participants were divided into two groups: an intervention group and a control group. Patients in the intervention group were provided with access to the web-based 'Sağlıkta Buluşalım (Meet in Health) Supportive Care Program' for 3 months in addition to routine care, while the control group received standard care. Data collection tools included a Descriptive Information Form, Edmonton Symptom Assessment System (ESAS), Functional Assessment of Cancer Therapy-Colorectal (FACT-C), Website Usability Scale, and a Telephone Follow-up Form. Statistical analyses, including Mann-Whitney U, Pearson Chi-Square, Fisher's Exact, and Friedman tests, were planned to compare symptom levels and quality of life scores within and between groups over time.
- Being tested
- web based supportive care programme
- Keywords
- Colorectal Neoplasms, Quality of Life, Internet-Based Intervention, Symptom Control, Colorectal Cancer, Supportive Care
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based supportive care programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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 |
| intervention group | Experimental | 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. Receives: Other: web based supportive care programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Measured by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Scale
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.
Measured: From enrollment to the end of treatment at 3 months
Symptom Severity Measured by the Edmonton Symptom Assessment Scale
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.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start8 Aug 2025
- Primary completion3 Jan 2026
- Study completion30 Jan 2026
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The web-based supportive care program developed for this study was developed within the framework of supportive care. Developed by Margaret Fitch in 1994, the Supportive Care Framework is a holistic model designed to plan and organize service delivery for individuals living with cancer and their families (Fitch, 1994). This framework aims to guide cancer care professionals and managers in conceptualizing how to provide the assistance and services patients may need. The framework emphasizes that cancer care is not limited to medical treatment but also encompasses support needs in all areas affecting quality of life. • Fitch, M.I. (1994). Providing supportive care for individuals living with cancer (Task Force Report). Toronto: Ontario Cancer Treatment and Research Foundation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilknur Yazicioglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilknur Yazicioglu, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512726
- Sponsor's protocol ID
- 2024/11-07
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Evaluation of The Effectiveness of A Web-Based Support Care Program for Individuals Diagnosed With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07512726
- Acronym / sponsor ID
- 2024/11-07
- Keywords
- Colorectal Neoplasms, Quality of Life, Internet-Based Intervention, Symptom Control, Colorectal Cancer, Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ilknur YaziciogluUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 6 Apr 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.
This study was designed to develop and evaluate the effectiveness of a web-based supportive care program for individuals diagnosed with colorectal cancer undergoing cancer treatment. The program's effectiveness is evaluated based on the symptom burden and quality of life experienced by patients during cancer treatment. This randomized controlled trial was conducted with the participation of patients diagnosed with colorectal cancer receiving treatment at the Outpatient Chemotherapy Unit of Koç University Hospital. Participants were divided into two groups: an intervention group and a control group. Patients in the intervention group were provided with access to the web-based 'Sağlıkta Buluşalım (Meet in Health) Supportive Care Program' for 3 months in addition to routine care, while the control group received standard care. Data collection tools included a Descriptive Information Form, Edmonton Symptom Assessment System (ESAS), Functional Assessment of Cancer Therapy-Colorectal (FACT-C), Website Usability Scale, and a Telephone Follow-up Form. Statistical analyses, including Mann-Whitney U, Pearson Chi-Square, Fisher's Exact, and Friedman tests, were planned to compare symptom levels and quality of life scores within and between groups over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The web-based supportive care program developed for this study was developed within the framework of supportive care. Developed by Margaret Fitch in 1994, the Supportive Care Framework is a holistic model designed to plan and organize service delivery for individuals living with cancer and their families (Fitch, 1994). This framework aims to guide cancer care professionals and managers in conceptualizing how to provide the assistance and services patients may need. The framework emphasizes that cancer care is not limited to medical treatment but also encompasses support needs in all areas affecting quality of life. • Fitch, M.I. (1994). Providing supportive care for individuals living with cancer (Task Force Report). Toronto: Ontario Cancer Treatment and Research Foundation
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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 |
| intervention group | Experimental | Other: web based supportive care programmeExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| web based supportive care programmeThis 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. | Other | intervention group |
Primary outcome
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.
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.
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 6 Apr 2026.
- Web-Based Supportive Care Program for Colorectal Cancer PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 web based supportive care programme in people with Colorectal Cancer and Colorectal (Colon or Rectal) Cancer, run by Ilknur Yazicioglu 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 7 inclusion and 5 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 6 Apr 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?
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 study lists 2 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 6 Apr 2026.