Multidimensional Examination of Patients with Colorectal and Anal Cancer

Recruiting

• Conditions: Colorectal Cancer; Fecal Incontinence; Quality of Life; Physical Inactivity; Anal Cancer
• Interventions: Other: No intervention - cross-sectional observational study

• Registration Number: NCT06562140
• Lead Sponsor: University of Pecs

Brief Summary

The aim of our cross-sectional research is to assess changes in physical activity, functional capacity, and health status in individuals with colorectal and anal carcinoma using subjective measurement tools, with particular focus on those suffering from incontinence, through a cross-sectional study. Additionally, the research involves the Hungarian adaptation and validation of the quality of life questionnaire for colorectal cancer (EORTC QLQ-CR29), quality of life questionnaire for anal cancer (EORTC QLQ-AN27), and Fecal Incontinence Severity Index (FISI)" questionnaires.

Detailed Description

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide. The incidence of CRC is known to be high in developed countries and increases with socioeconomic development. Well-known risk factors include aging, alcohol consumption, smoking, and obesity. In addition to family history, lifestyle changes in diet, occupation, or physical activity may also emerge as risk factors for CRC. Previous research findings have shown a significant association between reduced physical activity and an increased risk of CRC. With improved patient survival rates, functional outcomes such as fecal incontinence, urinary, and sexual dysfunction are becoming increasingly important, as they are known to significantly impact quality of life (QoL). Reviewing the functional outcomes of rectal cancer surgeries, it is observed that even years after surgery, one-third of patients suffer from fecal incontinence. In contrast, studies on the functional outcomes following colon cancer surgeries are rare and often involve relatively small study populations. Previous studies have shown that physical activity in cancer survivors can have numerous beneficial health effects and is associated with a reduced risk of cancer recurrence and mortality in cases of colon and rectal cancer.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-15
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-20
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma

Exclusion Criteria

• Neuromuscular diseases
• severe congenital musculoskeletal and other disorders,
• severe psychiatric illness, lack of cooperation,
• undergone other surgical procedures within the past year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anal cancer patients	No intervention - cross-sectional observational study	Patients aged 18 to 80 years with a diagnosis of anal carcinoma
Colorectal cancer patients	No intervention - cross-sectional observational study	Patients aged 18 to 80 years with a diagnosis of colorectal carcinoma

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29	Baseline	The EORTC QLQ-CR29 questionnaire assesses the general impact of cancer and its treatment among colorectal cancer patients. The minimum value is 29, maximum 116, where higher scores means worse health-related quality of life
FECAL INCONTINENCE SEVERITY INDEX (FISI)	Baseline	The questionnaire measures the frequency of the different incontinence events and the type of stool involved. The index provides a numerical score that reflects the overall severity of a patient's fecal incontinence. A total score is the sum of all points between 0 to 61, where the higher the score means more severe fecal incontinence.
Quality of life questionnaire for cancer patients - EORTC QLQ-C30	Baseline	The EORTC QLQ-C30 questionnaire examines the general impact of cancer and its treatment. The minimum value is 30, maximum 120, where higher scores means worse health-related quality of life.
Quality of life questionnaire for anal cancer - EORTC QLQ-AN27	Baseline	The EORTC QLQ-CR29 questionnaire assesses the general impact of cancer and its treatment among anal cancer patients. The minimum value is 27, maximum 108, where higher scores means worse health-related quality of life
Global Physical Activity Questionnaire (GPAQ)	1 week	To measure physical activity patterns related to work, active transportation, leisure time activities and sitting time. The work time physical activity, active transportation, recreational activities and sitting time will be summarized as weekly minutes.

Trial Locations

Locations (1)

University of Pécs; 🇭🇺 Pécs, Hungary