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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Fatigue; Iron-deficiency; Cognitive Impairment; Colorectal Cancer; Iron Deficiency Anemia
• Intervention / Treatment: Diagnostic test: iron deficiency

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Aabenraa, Region Of Southern Denmark, Denmark, 6200
      • Sygehus Sønderjylland
    • Esbjerg, Region Of Southern Denmark, Denmark, 6700
      • Hospital of South West Jutland
    • Grindsted, Region Of Southern Denmark, Denmark, 7200
      • Hospital of South West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

see inclusion criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iron deficient; ferritin<30 or Transferine saturation<.2	Diagnostic test: iron deficiency; Its not an intervention. Its an observational study. The groups are defined based on their iron status
iron replete; opposite of the other group	Diagnostic test: iron deficiency; Its not an intervention. Its an observational study. The groups are defined based on their iron status

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative run	the ability of the above mentioned test to predict the postoperative run (complications/length of stay)	30-days postoperatively

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Investigators: Study Director: Torben Knudsen, ass. prof, Institute of regional health research, regional of southern denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Fatigue; Anemia, Iron-Deficiency; Iron Deficiencies
• Other Study ID Numbers: 21 6250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No