Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
研究概览
简要总结
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment.
The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF).
- •Proficient in reading, comprehending, and conversing in Dutch.
- •Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.
排除标准
- •The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
- •Experienced fecal incontinence prior to undergoing surgery.
- •Are affected by neurological disorders affecting bowel function.
- •Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
- •Has a permanent stoma.
研究组 & 干预措施
TME/PME
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).
干预措施: Electronic bowel diary (Diagnostic Test)
TME/PME
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).
干预措施: Faecal Incontinence Quality of Life questionnaire (FIQL) (Diagnostic Test)
TME/PME
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).
干预措施: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) (Diagnostic Test)
Active surveillance
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).
干预措施: Electronic bowel diary (Diagnostic Test)
Active surveillance
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).
干预措施: Faecal Incontinence Quality of Life questionnaire (FIQL) (Diagnostic Test)
Active surveillance
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).
干预措施: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) (Diagnostic Test)
结局指标
主要结局
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
时间窗: 12 months
Faecal Incontinence Quality of Life questionnaire (FIQL) will be used for the evaluation of QoL related to faecal incontinence problems. The FIQL is a reliable and valid 41-item questionnaire, resulting in 4 subscales: Lifestyle, Coping/behavior, Depression/Self Perception and Embarrassment. The Scales ranges from 1 to 5, with a 1 indicating a lower functional status of quality of life. This questionnaire is also validated in Dutch.
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment
时间窗: 12 months
EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) will be used to assess overall quality of life (QoL). The EQ-5D-5L is a reliable and valid 6-item questionnaire, consisting of two parts: the social perspective and the individual perspective of one's own health. In the social perspective, the health state is converted into a value set with a score ranging from 0 to 1, where 0 represents being dead and 1 represents full health. The individual perspective assesses the respondent's own perception of their health, with a score ranging from 0 to 100. This questionnaire is validated in Dutch and widely used to measure general health-related quality of life.
Bowel symptoms after rectal cancer treatment
时间窗: 12 months
To ensure that patients can report all their bowel symptoms where they suffer from, a valid, reliable, user-friendly, and easy-to-interpret electronic bowel diary has been developed in another research project for which approval has already been obtained from the Ethical Committee of the University Hospitals Leuven (S68746). This electronic bowel diary will be used to map out all bowel complaints.
次要结局
- The predictive value of 'baseline age' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(pre-operatively, prior to the surgical intervention for rectal cancer)
- The predictive value of 'gender' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(pre-operatively, prior to the surgical intervention for rectal cancer)
- The predictive value of 'diabetes' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(pre-operatively, prior to the surgical intervention for rectal cancer)
- The predictive value of 'smoking history' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(pre-operatively, prior to the surgical intervention for rectal cancer)
- The predictive value of 'BMI' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(pre-operatively, prior to the surgical intervention for rectal cancer)
- The predictive value of 'defecation functions' measured with the MSKCC-BFI for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'defecation functions' measured with the LARS score for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'defecation functions' measured with the PAC-SYM for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'depression' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'anxiety' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'resilience' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(12 months)
- The predictive value of 'Optimal physiotherapy care' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(at 6 months post-surgery or post-stoma closure)
- The predictive value of 'Treatment-related factors' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure(At 1 month post-surgery or post-stoma closure)