Multidimensional Examination of Patients with Colorectal and Anal Cancer (MECACP)

January 20, 2025 updated by: Alexandra Makai, University of Pecs

Multidimensional Examination of Physical Activity, Functional Capacity, and Health Status in Patients with Colorectal and Anal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Márta Hock, PhD habil
  • Phone Number: +36209968995

Study Locations

  • Hungary
      • Pécs, Hungary
        • Recruiting
        • University of Pecs
        • Contact:
    • Baranya
      • Pécs, Baranya, Hungary, 7621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire for cancer patients - EORTC QLQ-C30
Time Frame: 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.
Baseline
Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29
Time Frame: 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
Baseline
Quality of life questionnaire for anal cancer - EORTC QLQ-AN27
Time Frame: 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
Baseline
Global Physical Activity Questionnaire (GPAQ)
Time Frame: 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.
1 week
FECAL INCONTINENCE SEVERITY INDEX (FISI)
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9636-PTE-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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