Colorectal CancerMECACPNCT06562140
Multidimensional Examination of Patients with Colorectal and Anal Cancer
An observational study of Colorectal Cancer and Anal Cancer, run by University of Pecs at 2 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Anal Cancer, Physical Inactivity
- How many people
- 300 participants
- Where
- 2 sitesHungary
- Study dates
- 15 Aug 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma
Who cannot join
- Neuromuscular diseases
- severe congenital musculoskeletal and other disorders,
- severe psychiatric illness, lack of cooperation,
- undergone other surgical procedures within the past year.
Trial locations and contacts
2 sites in 1 country.
Márta Hock, PhD habil contact
Hungary2 sites, 2 recruiting
- Not yet recruiting
University of Pécs
Pécs, Baranya, 7621
Alexandra Makai, PhD, +36307213156, alexandra.makai@etk.pte.hu
Márta Hock, PhD habil, +36209968995, hock.marta@etk.pte.hu
- Recruiting
University of Pécs
Pécs
Marta Hock Hock, Ph.D., 003672501500, hock.marta@etk.pte.hu
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention - cross-sectional observational study
- Keywords
- colorectal cancer, anal cancer, quality of life, physical activity, fecal incontinence
- Medical subject headings
- Colorectal Neoplasms, Anus Neoplasms, Sedentary Behavior, Fecal Incontinence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - cross-sectional observational studyOther
No intervention - cross-sectional observational study
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Patients aged 18 to 80 years with a diagnosis of colorectal carcinoma Receives: Other: No intervention - cross-sectional observational study | |
| Anal cancer patients | Patients aged 18 to 80 years with a diagnosis of anal carcinoma Receives: Other: No intervention - cross-sectional observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire for cancer patients - EORTC QLQ-C30
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.
Measured: Baseline
Quality of life questionnaire for colorectal cancer - EORTC QLQ-CR29
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
Measured: Baseline
Quality of life questionnaire for anal cancer - EORTC QLQ-AN27
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
Measured: Baseline
Global Physical Activity Questionnaire (GPAQ)
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.
Measured: 1 week
FECAL INCONTINENCE SEVERITY INDEX (FISI)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Makai, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562140
- Sponsor's protocol ID
- 9636-PTE-2023
- Acronym
- MECACP
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Examination of Physical Activity, Functional Capacity, and Health Status in Patients with Colorectal and Anal Cancer
- ClinicalTrials.gov ID
- NCT06562140
- Acronym / sponsor ID
- MECACP / 9636-PTE-2023
- Keywords
- colorectal cancer, anal cancer, quality of life, physical activity, fecal incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Other: No intervention - cross-sectional observational studyPatients aged 18 to 80 years with a diagnosis of colorectal carcinoma |
| Anal cancer patients | – | Other: No intervention - cross-sectional observational studyPatients aged 18 to 80 years with a diagnosis of anal carcinoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma
Key exclusion criteria (4 listed)
- Neuromuscular diseases
- severe congenital musculoskeletal and other disorders,
- severe psychiatric illness, lack of cooperation,
- undergone other surgical procedures within the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - cross-sectional observational studyNo intervention - cross-sectional observational study | Other | Anal cancer patients, Colorectal cancer patients |
Primary outcome
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.
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
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márta Hock, PhD habil contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Anal Cancer, run by University of Pecs at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Makai, PhD (+36307213156, alexandra.makai@etk.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire for cancer patients - EORTC QLQ-C30 (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.