- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910894
Health-related Quality of Life in Colon Cancer
April 10, 2019 updated by: Catarina Tiselius, Region Västmanland
Health-related Quality of Life in Colon Cancer Patients
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
See above.
Study Type
Observational
Enrollment (Actual)
376
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients diagnosed with colon cancer in Region Västmanland 2012-2016, that accepted to be included in the study after written consent.
Description
Inclusion Criteria:
All patients diagnosed with colon cancer in Region Västmanland 2012-2016.
Exclusion Criteria:
Language problems, declined inclusion,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related Quality of Life
Time Frame: 2012-2016
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catarina Tiselius, PhD, Region Västmanland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2012
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
March 31, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- HRQoL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
On request if suitable.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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