Multidimensional Examination of Patients with Colorectal and Anal Cancer

NCT ID: NCT06562140

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Anal Cancer Physical Inactivity Fecal Incontinence Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Colorectal cancer patients

Patients aged 18 to 80 years with a diagnosis of colorectal carcinoma

No intervention - cross-sectional observational study

Intervention Type OTHER

No intervention - cross-sectional observational study

Anal cancer patients

Patients aged 18 to 80 years with a diagnosis of anal carcinoma

No intervention - cross-sectional observational study

Intervention Type OTHER

No intervention - cross-sectional observational study

Interventions

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No intervention - cross-sectional observational study

No intervention - cross-sectional observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Makai

senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pécs

Pécs, Baranya, Hungary

Site Status NOT_YET_RECRUITING

University of Pécs

Pécs, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Alexandra Makai, PhD

Role: CONTACT

+36307213156

Márta Hock, PhD habil

Role: CONTACT

+36209968995

Facility Contacts

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Alexandra Makai, PhD

Role: primary

+36307213156

Márta Hock, PhD habil

Role: backup

+36209968995

Marta Hock Hock, Ph.D.

Role: primary

003672501500

Other Identifiers

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9636-PTE-2023

Identifier Type: -

Identifier Source: org_study_id

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