NCT03910894

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 12, 2019

Status Verified

March 1, 2019

Enrollment Period

7.5 years

First QC Date

March 31, 2019

Last Update Submit

April 10, 2019

Conditions

Health Related Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients diagnosed with colon cancer in Region Västmanland 2012-2016.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tiselius C, Johansen F, Rosenblad A, Smedh K. Health-related quality of life is a significant prognostic factor for recurrence and overall survival in patients with colon cancer. BMC Cancer. 2025 Jun 10;25(1):1016. doi: 10.1186/s12885-025-14254-1.

    PMID: 40495145DERIVED

  • Tiselius C, Rosenblad A, Strand E, Smedh K. Risk factors for poor health-related quality of life in patients with colon cancer include stoma and smoking habits. Health Qual Life Outcomes. 2021 Sep 10;19(1):216. doi: 10.1186/s12955-021-01850-5.

    PMID: 34507560DERIVED

Study Officials

  • Catarina Tiselius, PhD

    Region Västmanland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 10, 2019

Study Start

March 1, 2012

Primary Completion

September 1, 2019

Study Completion

September 1, 2022

Last Updated

April 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

On request if suitable.