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

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.

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.

Clinical Trials on Health Related Quality of Life

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