Colorectal CancerNCT07427901
Quality Of Life In Colorectal Cancer Survivors
A study testing Quality of Life Assessment in people with Colorectal Cancer and Colon Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- Quality of Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 May 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with colorectal cancer (colon or rectal cancer)
- Age 25 to 65 years
- First oncological treatment performed at the Institute of Oncology Ljubljana
- Working-capable patients
- Ability to complete questionnaires
- Ability to provide written informed consent
Who cannot join
- Age < 25 years or > 65 years
- Patients unable to complete questionnaires
- Patients unable to participate in follow-up assessments
- Patients who do not provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neža Gros contact
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
Neža Gros, ngros@onko-i.si
About this study
The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study aims to assess quality of life in colorectal cancer survivors in relation to psycho-physical-social well-being at different time points and to evaluate the prevalence of late adverse effects and their association with diagnosis and specific oncological treatment.
Read the detailed description
The purpose of this study is to identify late adverse effects in patients with colorectal cancer that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study will assess quality of life in colorectal cancer patients in relation to psycho-physical-social well-being at different time points. In addition, the study will identify and evaluate the prevalence of late adverse effects and analyze their association with diagnosis and specific oncological treatment.
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- Quality of Life Assessment
- Keywords
- Quality of Life, Cancer Survivors, Late Adverse Effects
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life AssessmentOther
Quality of life assessment using questionnaires at 6, 12, and 24 months after oncological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life Assessment Group | Experimental | Participants with colorectal cancer after oncological treatment will complete quality of life assessments at 6, 12, and 24 months to identify late adverse effects and evaluate psycho-physical-social well-being. Receives: Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Score (EORTC QLQ-C30 Global Health Status/QoL Scale)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), specifically the Global Health Status/Quality of Life scale (items 29 and 30). Scores will be linearly transformed to a 0 to 100 scale. Higher scores indicate better quality of life.
Measured: 6, 12, and 24 months after oncological treatment
Secondary outcomes (1)
Colorectal Cancer-Specific Quality of Life (EORTC QLQ-CR29)
Colorectal cancer-specific quality of life will be assessed using the EORTC QLQ-CR29 questionnaire. Scores will be linearly transformed to a 0 to 100 scale. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales.
Measured: 6, 12, and 24 months after oncological treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 May 2023
- Primary completion1 Jan 2024
- Study completion31 Dec 2027 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group study evaluating quality of life and late adverse effects in colorectal cancer patients at 6, 12, and 24 months after oncological treatment.
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427901
- Sponsor's protocol ID
- OIL_CCS_2023
- Other IDs
- ERIDNPVO-0051/2023, 0120-192/2023/6
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Of Life In Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT07427901
- Acronym / sponsor ID
- OIL_CCS_2023
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer
- Keywords
- Quality of Life, Cancer Survivors, Late Adverse Effects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 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.
The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study aims to assess quality of life in colorectal cancer survivors in relation to psycho-physical-social well-being at different time points and to evaluate the prevalence of late adverse effects and their association with diagnosis and specific oncological treatment.
Detailed description
The purpose of this study is to identify late adverse effects in patients with colorectal cancer that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study will assess quality of life in colorectal cancer patients in relation to psycho-physical-social well-being at different time points. In addition, the study will identify and evaluate the prevalence of late adverse effects and analyze their association with diagnosis and specific oncological treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study evaluating quality of life and late adverse effects in colorectal cancer patients at 6, 12, and 24 months after oncological treatment.
| Arm | Type | Receives |
|---|---|---|
| Quality of Life Assessment Group | Experimental | Other: Quality of Life AssessmentParticipants with colorectal cancer after oncological treatment will complete quality of life assessments at 6, 12, and 24 months to identify late adverse effects and evaluate psycho-physical-social well-being. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with colorectal cancer (colon or rectal cancer)
- Age 25 to 65 years
- First oncological treatment performed at the Institute of Oncology Ljubljana
- Working-capable patients
- Ability to complete questionnaires
Key exclusion criteria (4 listed)
- Age < 25 years or > 65 years
- Patients unable to complete questionnaires
- Patients unable to participate in follow-up assessments
- Patients who do not provide written informed consent
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 |
|---|---|---|
| Quality of Life AssessmentQuality of life assessment using questionnaires at 6, 12, and 24 months after oncological treatment. | Other | Quality of Life Assessment Group |
Primary outcome
Quality of Life Score (EORTC QLQ-C30 Global Health Status/QoL Scale)
Time frame: 6, 12, and 24 months after oncological treatment
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), specifically the Global Health Status/Quality of Life scale (items 29 and 30). Scores will be linearly transformed to a 0 to 100 scale. Higher scores indicate better quality of life.
1 secondary outcome
Colorectal Cancer-Specific Quality of Life (EORTC QLQ-CR29)
Time frame: 6, 12, and 24 months after oncological treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- 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.
Neža Gros contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Assessment in people with Colorectal Cancer and Colon Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Feb 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klavdija Korošec (+386 31630065, kkorosec@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Score (EORTC QLQ-C30 Global Health Status/QoL Scale) (time frame: 6, 12, and 24 months after oncological treatment). 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 23 Feb 2026.