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Recruiting NCT06562140

Multidimensional Examination of Patients with Colorectal and Anal Cancer

— Observational Colorectal Cancer Anal Cancer Physical Inactivity Fecal Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention - cross-sectional observational study.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Anal Cancer, Physical Inactivity, Fecal Incontinence. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No intervention - cross-sectional observational study
    No intervention - cross-sectional observational study

Primary outcome measures

  • Quality of life questionnaire for cancer patients - EORTC QLQ-C30 [Time frame: Baseline]
  • Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29 [Time frame: Baseline]
  • Quality of life questionnaire for anal cancer - EORTC QLQ-AN27 [Time frame: Baseline]
  • Global Physical Activity Questionnaire (GPAQ) [Time frame: 1 week]
  • FECAL INCONTINENCE SEVERITY INDEX (FISI) [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hungary · 2 centers
  • University of Pécs — Pécs
  • University of Pécs — Pécs

Identifiers

NCT: NCT06562140 · 9636-PTE-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗