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

NCT04749589 | Completed

• 1 other identifier: 21 6250
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Fatigue sub-scale of Focussed assessment of cancer treatment - anemia

  up to one months after inclusion

Secondary Outcomes (5)

• Quality of life

  up to one months after inclusion

• Cognitive ability

  up to one months after inclusion

• endurance

  up to one months after inclusion

• peripheral muscular strengths

  up to one months after inclusion

• mobility and balance

  up to one months after inclusion

Other Outcomes (1)

• post-operative run

  30-days postoperatively

Study Arms (2)

iron deficient

ferritin\<30 or Transferine saturation\<.2

Diagnostic Test: iron deficiency

iron replete

opposite of the other group

Diagnostic Test: iron deficiency

Interventions

iron deficiency DIAGNOSTIC_TEST

Its not an intervention. Its an observational study. The groups are defined based on their iron status

iron deficient; iron replete

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

see inclusion criteria

You may qualify if:

• patients in whom endoscopy has raised suspicion of colorectal malignancy

You may not qualify if:

• non fluent in Danish language
• cerebral impairment (ex severe dementia) so that informed consent can not be obtained

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (3)

Sygehus Sønderjylland

Aabenraa, Region Syddanmark, 6200, Denmark

Location

Hospital of South West Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Hospital of South West Jutland

Grindsted, Region Syddanmark, 7200, Denmark

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Colorectal Neoplasms; Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Torben Knudsen, ass. prof

  Institute of regional health research, regional of southern denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 11, 2021
• Study Start: February 11, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)