Pilot Research on Individualized Comprehensive Rehabilitation of Patients With Colorectal Cancer 2022-2024
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. Participants and investigators are aware of group assignment. Outcomes are assessed using standardized patient-reported questionnaires at baseline, 6 months, and 12 months after diagnosis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Individualized Comprehensive Rehabilitation
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.
干预措施: Individualized Comprehensive Rehabilitation (Behavioral)
Control: Usual Care (Standard Oncology Follow-up)
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.
结局指标
主要结局
Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)
时间窗: 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.
次要结局
- Change in Patient-Reported Problems Assessed by Triage Questionnaire(Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis)
- Duration of Sick Leave (Absenteeism)(Up to 12 months after diagnosis)
- Disability Retirement Rate(Through study completion (up to 24 months))