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NCT Number: NCT06562140

Multidimensional Examination of 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.

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Key information

Conditions

Colorectal Cancer Anal Cancer Anus Diseases Anus Neoplasms Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fecal Incontinence Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Physical Inactivity Quality of Life Rectal Diseases Rectal Neoplasms Sedentary Behavior

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pécs, Pécs, Baranya, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention - cross-sectional observational study

Other

No intervention - cross-sectional observational study

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Makai, PhD

CONTACT

[email protected]

+36307213156

Márta Hock, PhD habil

CONTACT

+36209968995

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Acronym: MECACP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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