Clinical trial NCT06562140: Multidimensional Examination of Patients with Colorectal and Anal Cancer
Official title: Multidimensional Examination of Physical Activity, Functional Capacity, and Health Status in Patients with Colorectal and Anal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Anal Cancer
Physical Inactivity
Fecal Incontinence
Quality of Life
Keywords: colorectal cancer
anal cancer
quality of life
physical activity
fecal incontinence
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Quality of life questionnaire for cancer patients - EORTC QLQ-C30
timeFrame: Baseline
measure: Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29
timeFrame: Baseline
measure: Quality of life questionnaire for anal cancer - EORTC QLQ-AN27
timeFrame: Baseline
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: 1 week
measure: FECAL INCONTINENCE SEVERITY INDEX (FISI)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
state: Baranya
city: Pécs
country: Hungary
facility: University of Pécs
Study officials:
References: