Colon CancerNCT07428239
Pilot Study of Individualized Comprehensive Rehabilitation in Patients With Colorectal Cancer
A study testing Individualized Comprehensive Rehabilitation in people with Colon Cancer and Rectal Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This study is a pilot interventional study evaluating an individualized, comprehensive rehabilitation approach for patients with colorectal cancer in Slovenia. Patients treated for colorectal cancer often experience long-term physical, psychological, and social consequences of the disease and its treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Individualized Comprehensive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2022to 30 Sep 2024
- 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
- Adult patients (≥18 years) with histologically confirmed colorectal cancer
- Patients who have completed primary oncological treatment (surgery ± systemic therapy and/or radiotherapy)
- Patients eligible for and willing to participate in an individualized comprehensive rehabilitation program
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Severe cognitive impairment or psychiatric condition preventing participation
- Uncontrolled comorbidities that contraindicate participation in rehabilitation (e.g. severe cardiovascular instability)
- Inability to participate in follow-up assessments
- Concurrent participation in another interventional clinical study that could interfere with study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Research on Individualized Comprehensive Rehabilitation of Patients With Colorectal Cancer 2022-2024
This study is a pilot interventional study evaluating an individualized, comprehensive rehabilitation approach for patients with colorectal cancer in Slovenia. Patients treated for colorectal cancer often experience long-term physical, psychological, and social consequences of the disease and its treatment. Currently, rehabilitation services are not provided in a coordinated or systematic way. The aim of this study is to identify patients' rehabilitation needs and to assess the feasibility and potential benefits of a coordinated multidisciplinary rehabilitation pathway. Participants are guided through an individualized rehabilitation pathway and referred to appropriate healthcare professionals (e.g., physiotherapists, dietitians, psychologists, physicians, and other specialists) according to their needs. No experimental medications or devices are used. Results will support the development of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.
Read the detailed description
This study evaluates the feasibility and potential benefits of an individualized, coordinated comprehensive rehabilitation pathway for patients with colorectal cancer in Slovenia. Patients with colorectal cancer frequently experience long-term physical symptoms, psychological distress, and social or occupational difficulties as a consequence of the disease and its oncological treatment. Despite improved survival rates, comprehensive rehabilitation is not systematically implemented in Slovenia, and supportive services are typically delivered in a fragmented and non-coordinated manner.
The study is designed as a prospective, non-randomized, controlled pilot interventional study conducted at the Institute of Oncology Ljubljana. A total of 150 adult patients with colorectal cancer will be included and assigned to either a control group (usual care) or an intervention group (coordinated individualized comprehensive rehabilitation), with 75 participants in each group.
Participants in both groups complete standardized patient-reported outcome measures assessing health-related quality of life (EORTC QLQ-C30 and EORTC QLQ-CR29) and a structured triage questionnaire assessing patient-reported problems across multiple domains. Assessments are performed at baseline (at diagnosis), and at follow-up visits approximately 6 months and 12 months after diagnosis.
The control group receives standard oncological follow-up care. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist.
Participants in the intervention group are managed through a coordinated rehabilitation pathway. Based on questionnaire results and clinical evaluation, patients are assessed by a rehabilitation coordinator, and their needs are reviewed by a multidisciplinary team. Participants are referred to appropriate rehabilitation services according to predefined rehabilitation recommendations and available provider networks. Rehabilitation may include physical rehabilitation and exercise counseling, nutritional counseling, psychological support, and other supportive care interventions tailored to individual needs.
The primary objective of the study is to assess changes in health-related quality of life over time and to evaluate whether a coordinated rehabilitation approach is feasible and potentially beneficial for patients with colorectal cancer. Secondary objectives include evaluation of patient-reported problems, as well as work-related outcomes such as duration of sick leave and disability retirement rates.
The results of this pilot study will support future planning and implementation of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Individualized Comprehensive Rehabilitation
- Keywords
- Comprehensive rehabilitation, Cancer rehabilitation
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Comprehensive RehabilitationBehavioural
A personalized, multidisciplinary rehabilitation intervention tailored to individual patient needs, including supervised physical exercise, nutritional counseling, psychological support, and education aimed at improving functional capacity, recovery, and quality of life in patients with colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Comprehensive Rehabilitation | Experimental | Participants receive an individualized, multidisciplinary comprehensive rehabilitation program following treatment for colorectal cancer. The program includes physical, nutritional, psychological, and supportive components tailored to individual needs. Receives: Behavioral: Individualized Comprehensive Rehabilitation |
| Control: Usual Care (Standard Oncology Follow-up) | No intervention | Participants receive standard oncological follow-up care after diagnosis and treatment of colorectal cancer. Participants complete study questionnaires at baseline, 6 months, and 12 months. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist. No coordinated rehabilitation pathway is provided as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)
Health-related quality of life (HRQoL) is assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires: EORTC QLQ-C30 (core cancer quality of life questionnaire) and EORTC QLQ-CR29 (colorectal cancer-specific module). Questionnaire responses are scored according to EORTC scoring manuals and transformed to a 0-100 scale. Changes in HRQoL domains (global health status, functional scales, and symptom scales) are evaluated over time. Higher scores on functional scales and global health status represent better quality of life, while higher scores on symptom scales represent worse symptom burden.
Measured: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Secondary outcomes (3)
Change in Patient-Reported Problems Assessed by Triage Questionnaire
Patient-reported problems are assessed using a structured triage questionnaire covering 17 domains of physical, psychological, social, and functional difficulties. Changes in the number and severity of reported problems over time are evaluated to assess rehabilitation needs and response to the rehabilitation pathway.
Measured: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Duration of Sick Leave (Absenteeism)
Work absenteeism is assessed as the total duration of sick leave during follow-up. The duration of sick leave is compared between the intervention group and the control group to evaluate the impact of coordinated comprehensive rehabilitation on return-to-work outcomes.
Measured: Up to 12 months after diagnosis
Disability Retirement Rate
Disability retirement is assessed as the proportion of participants who apply for or receive disability retirement (partial or full) during follow-up. Rates are compared between the intervention group and the control group.
Measured: Through study completion (up to 24 months)
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 Oct 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Participants are assigned to either an intervention group receiving coordinated individualized comprehensive rehabilitation or a control group receiving usual care (standard oncology follow-up). Outcomes are assessed using standardized questionnaires at baseline (at diagnosis), 6 months, and 12 months after diagnosis to evaluate feasibility and changes in quality of life and patient-reported problems.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
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
- NCT07428239
- Sponsor's protocol ID
- OI_PILKO-2022
- Status last verified
- Feb 2026
- First submitted
- 4 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
- Pilot Research on Individualized Comprehensive Rehabilitation of Patients With Colorectal Cancer 2022-2024
- ClinicalTrials.gov ID
- NCT07428239
- Acronym / sponsor ID
- OI_PILKO-2022
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Comprehensive rehabilitation, Cancer rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- 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.
This study is a pilot interventional study evaluating an individualized, comprehensive rehabilitation approach for patients with colorectal cancer in Slovenia. Patients treated for colorectal cancer often experience long-term physical, psychological, and social consequences of the disease and its treatment. Currently, rehabilitation services are not provided in a coordinated or systematic way. The aim of this study is to identify patients' rehabilitation needs and to assess the feasibility and potential benefits of a coordinated multidisciplinary rehabilitation pathway. Participants are guided through an individualized rehabilitation pathway and referred to appropriate healthcare professionals (e.g., physiotherapists, dietitians, psychologists, physicians, and other specialists) according to their needs. No experimental medications or devices are used. Results will support the development of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.
Detailed description
This study evaluates the feasibility and potential benefits of an individualized, coordinated comprehensive rehabilitation pathway for patients with colorectal cancer in Slovenia. Patients with colorectal cancer frequently experience long-term physical symptoms, psychological distress, and social or occupational difficulties as a consequence of the disease and its oncological treatment. Despite improved survival rates, comprehensive rehabilitation is not systematically implemented in Slovenia, and supportive services are typically delivered in a fragmented and non-coordinated manner.
The study is designed as a prospective, non-randomized, controlled pilot interventional study conducted at the Institute of Oncology Ljubljana. A total of 150 adult patients with colorectal cancer will be included and assigned to either a control group (usual care) or an intervention group (coordinated individualized comprehensive rehabilitation), with 75 participants in each group.
Participants in both groups complete standardized patient-reported outcome measures assessing health-related quality of life (EORTC QLQ-C30 and EORTC QLQ-CR29) and a structured triage questionnaire assessing patient-reported problems across multiple domains. Assessments are performed at baseline (at diagnosis), and at follow-up visits approximately 6 months and 12 months after diagnosis.
The control group receives standard oncological follow-up care. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist.
Participants in the intervention group are managed through a coordinated rehabilitation pathway. Based on questionnaire results and clinical evaluation, patients are assessed by a rehabilitation coordinator, and their needs are reviewed by a multidisciplinary team. Participants are referred to appropriate rehabilitation services according to predefined rehabilitation recommendations and available provider networks. Rehabilitation may include physical rehabilitation and exercise counseling, nutritional counseling, psychological support, and other supportive care interventions tailored to individual needs.
The primary objective of the study is to assess changes in health-related quality of life over time and to evaluate whether a coordinated rehabilitation approach is feasible and potentially beneficial for patients with colorectal cancer. Secondary objectives include evaluation of patient-reported problems, as well as work-related outcomes such as duration of sick leave and disability retirement rates.
The results of this pilot study will support future planning and implementation of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either an intervention group receiving coordinated individualized comprehensive rehabilitation or a control group receiving usual care (standard oncology follow-up). Outcomes are assessed using standardized questionnaires at baseline (at diagnosis), 6 months, and 12 months after diagnosis to evaluate feasibility and changes in quality of life and patient-reported problems.
| Arm | Type | Receives |
|---|---|---|
| Individualized Comprehensive Rehabilitation | Experimental | Behavioral: Individualized Comprehensive RehabilitationParticipants receive an individualized, multidisciplinary comprehensive rehabilitation program following treatment for colorectal cancer. The program includes physical, nutritional, psychological, and supportive components tailored to individual needs. |
| Control: Usual Care (Standard Oncology Follow-up) | No intervention | –Participants receive standard oncological follow-up care after diagnosis and treatment of colorectal cancer. Participants complete study questionnaires at baseline, 6 months, and 12 months. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist. No coordinated rehabilitation pathway is provided as part 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 (4 listed)
- Adult patients (≥18 years) with histologically confirmed colorectal cancer
- Patients who have completed primary oncological treatment (surgery ± systemic therapy and/or radiotherapy)
- Patients eligible for and willing to participate in an individualized comprehensive rehabilitation program
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (4 listed)
- Severe cognitive impairment or psychiatric condition preventing participation
- Uncontrolled comorbidities that contraindicate participation in rehabilitation (e.g. severe cardiovascular instability)
- Inability to participate in follow-up assessments
- Concurrent participation in another interventional clinical study that could interfere with study outcomes
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 |
|---|---|---|
| Individualized Comprehensive RehabilitationA personalized, multidisciplinary rehabilitation intervention tailored to individual patient needs, including supervised physical exercise, nutritional counseling, psychological support, and education aimed at improving functional capacity, recovery, and quality of life in patients with colorectal cancer. | Behavioural | Individualized Comprehensive Rehabilitation |
Primary outcome
Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)
Time frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Health-related quality of life (HRQoL) is assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires: EORTC QLQ-C30 (core cancer quality of life questionnaire) and EORTC QLQ-CR29 (colorectal cancer-specific module). Questionnaire responses are scored according to EORTC scoring manuals and transformed to a 0-100 scale. Changes in HRQoL domains (global health status, functional scales, and symptom scales) are evaluated over time. Higher scores on functional scales and global health status represent better quality of life, while higher scores on symptom scales represent worse symptom burden.
3 secondary outcomes
Change in Patient-Reported Problems Assessed by Triage Questionnaire
Time frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Duration of Sick Leave (Absenteeism)
Time frame: Up to 12 months after diagnosis
Disability Retirement Rate
Time frame: Through study completion (up to 24 months)
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 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. 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 Individualized Comprehensive Rehabilitation in people with Colon Cancer and Rectal 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 4 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: finished, 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?
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 in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores) (time frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis). 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.