Health-related Quality of Life in Colon Cancer NCT03910894

Updated 05/17/2024

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT03910894
Other study ID #	HRQoL
Secondary ID
Status	Active, not recruiting
Phase
First received
Last updated
Start date	March 2012
Est. completion date	September 2022

Study information
Verified date	March 2019
Source	Region Västmanland
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

This study investigates health-related Quality of life in colon cancer patients in Västmanland, Sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated EORTC QLQ-C30 questionnaire.

Description:

See above.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	376
Est. completion date	September 2022
Est. primary completion date	September 2019
Accepts healthy volunteers	No
Gender	All
Age group	N/A and older
Eligibility	Inclusion Criteria: All patients diagnosed with colon cancer in Region Västmanland 2012-2016. Exclusion Criteria: Language problems, declined inclusion,

Study Design

Related Conditions & MeSH terms

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Region Västmanland

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life	The EORTC QLQ-C30, a HRQoL questionnaire was used. It consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain). Six single items are also included (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). The final two items in the questionnaire assess global health and overall QoL. Raw data were transformed to standardized scores ranging from 0 to 100 using the EORTC scoring manual. A high score on the functional scale represents a high level of functioning (i.e., higher is better), whereas a high score on the symptom scale represents a high level of symptoms (i.e., lower is better).	2012-2016

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