QoLiCOL - Quality of Life in Colon Cancer

Colonic Neoplasm Clinical Trial

— QoLiCOL  

Official title:

QoLiCOL - Quality of Life in Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02530593
• Other study ID #: QoLiCOL
• Status: Active, not recruiting
• Start date: June 2015
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

Description:

QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: September 2025
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colon cancer newly diagnosed.

• Planned treatment presented

Exclusion Criteria:

• No Colon cancer diagnosis,

• below 18 years of age,

• no informed consent or withdrawn informed consent.

Related Conditions & MeSH terms

• Colonic Neoplasm
• Colonic Neoplasms

Intervention

Behavioral:
• There is no intervention, only observation

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital/Östra	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL in colon cancer patients	The primary end-point is to describe QoL, symptoms and functional impairments in an unselected population of colon cancer patients	3 years
Secondary	Generate basic descriptive data of the patient population, such as demography, socioeconomic data, disease stage at diagnosis, type of treatment, recurrence and survival		3 years
Secondary	Compare differences in QoL between patients with different tumour levels		3 years
Secondary	Detect differences in QoL in patients over time after colon cancer treatment		3 years
Secondary	Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation		3 years
Secondary	Evaluate the effect of coping strategies on QoL after initiated treatment		3 years
Secondary	Describe patient expectations at diagnosis of colon cancer		3 years
Secondary	Identify differences in QoL between patients in different groups regarding gender, age and education level		3 years
Secondary	Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL		3 years
Secondary	Identify areas of improvement in treatment and patient care		3 years
Secondary	Enable initiation interventional studies when appropriate		3 years
Secondary	Analyse health economy aspects of QoL and morbidity in the patient population		3 years