Multidimensional Examination of Patients with Colorectal and Anal Cancer
MECACP
1 other identifier
observational
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2024
CompletedFirst Submitted
Initial submission to the registry
August 16, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJanuary 23, 2025
August 1, 2024
1 year
August 16, 2024
January 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Quality of life questionnaire for cancer patients - EORTC QLQ-C30
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.
Baseline
Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29
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
Baseline
Quality of life questionnaire for anal cancer - EORTC QLQ-AN27
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
Baseline
Global Physical Activity Questionnaire (GPAQ)
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.
1 week
FECAL INCONTINENCE SEVERITY INDEX (FISI)
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.
Baseline
Study Arms (2)
Colorectal cancer patients
Patients aged 18 to 80 years with a diagnosis of colorectal carcinoma
Anal cancer patients
Patients aged 18 to 80 years with a diagnosis of anal carcinoma
Interventions
No intervention - cross-sectional observational study
Eligibility Criteria
The study population is colorectal or anal cancer patients older than 18 years. Neuromuscular diseases, severe congenital musculoskeletal and other disorders, severe psychiatric illness, lack of cooperation, undergone other surgical procedures within the past year.
You may qualify if:
- adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma
You may not qualify if:
- Neuromuscular diseases
- severe congenital musculoskeletal and other disorders,
- severe psychiatric illness, lack of cooperation,
- undergone other surgical procedures within the past year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Pécs
Pécs, Baranya, 7621, Hungary
University of Pécs
Pécs, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior lecturer
Study Record Dates
First Submitted
August 16, 2024
First Posted
August 20, 2024
Study Start
August 15, 2024
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
January 23, 2025
Record last verified: 2024-08