Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

Study Overview
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Brief Summary
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The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.

Detailed Description
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Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available. The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.

Official Title
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Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy

Conditions
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Iron-deficiency, Iron Deficiency Anemia, Colorectal Cancer, Fatigue, Quality of Life, Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: iron deficiency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients in whom endoscopy has raised suspicion of colorectal malignancy Exclusion Criteria: non fluent in Danish language cerebral impairment (ex severe dementia) so that informed consent can not be obtained

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iron deficient<br>ferritin<30 or Transferine saturation<.2 | Diagnostic Test: iron deficiency<br>* Its not an intervention. Its an observational study. The groups are defined based on their iron status<br>|
| iron replete<br>opposite of the other group | Diagnostic Test: iron deficiency<br>* Its not an intervention. Its an observational study. The groups are defined based on their iron status<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Fatigue sub-scale of Focussed assessment of cancer treatment - anemia | up to one months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | European Organisation for Research and Treatment of Cancer C30 | up to one months after inclusion | 
| Cognitive ability | Montreal cognitive assessment | up to one months after inclusion | 
| endurance | 6 minutes walk test | up to one months after inclusion | 
| peripheral muscular strengths | hand-held dynamometer | up to one months after inclusion | 
| mobility and balance | timed-up-and-go-test | up to one months after inclusion |