Health Related Quality of LifeNCT03910894
Health-related Quality of Life in Colon Cancer
An observational study of Health Related Quality of Life, run by Region Västmanland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Related Quality of Life
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with colon cancer in Region Västmanland 2012-2016, that accepted to be included in the study after written consent.
Who may be able to join
- All patients diagnosed with colon cancer in Region Västmanland 2012-2016.
Who cannot join
- Language problems, declined inclusion,
About this study
Official title: 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.
Read the detailed description
See above.
- Conditions
- Health Related Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2012-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study startMar 2012
- Primary completionSep 2019 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Tiselius, Region Västmanland
- Investigators
- Catarina Tiselius, PhD, Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910894
- Sponsor's protocol ID
- HRQoL
- Status last verified
- Mar 2019
- First submitted
- 31 Mar 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request if suitable.
Publications
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.
PubMed 40495145Tiselius 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.
PubMed 34507560
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life in Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT03910894
- Acronym / sponsor ID
- HRQoL
- Conditions
- Health Related Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with colon cancer in Region Västmanland 2012-2016, that accepted to be included in the study after written consent.
Key inclusion criteria (1 listed)
- All patients diagnosed with colon cancer in Region Västmanland 2012-2016.
Key exclusion criteria (1 listed)
- Language problems, declined inclusion,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Derived from this study: PubMed 40495145Tiselius 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.
- Derived from this study: PubMed 34507560Tiselius 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.
- Individual participant dataSharing planned: No. On request if suitable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Tiselius, PhD principal investigator
Region Västmanland
Questions about this trial
What is this clinical trial studying?
An observational study of Health Related Quality of Life, run by Region Västmanland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: 2012-2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.