QoLiCOL - Quality of Life in Colon Cancer

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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QoLiCOL - Quality of Life in Colon Cancer

Conditions
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Colonic Neoplasm

Intervention / Treatment
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* Behavioral: There is no intervention, only observation


Participation Criteria
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Eligibility Criteria
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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treatment presented Exclusion Criteria: No Colon cancer diagnosis, below 18 years of age, no informed consent or withdrawn informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with colon cancer<br>All patients presenting with a newly diagnosed colon cancer regardless of tumour stage | Behavioral: There is no intervention, only observation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Compare differences in QoL between patients with different tumour levels |  | 3 years | 
| Detect differences in QoL in patients over time after colon cancer treatment |  | 3 years | 
| Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation |  | 3 years | 
| Evaluate the effect of coping strategies on QoL after initiated treatment |  | 3 years | 
| Describe patient expectations at diagnosis of colon cancer |  | 3 years | 
| Identify differences in QoL between patients in different groups regarding gender, age and education level |  | 3 years | 
| Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL |  | 3 years | 
| Identify areas of improvement in treatment and patient care |  | 3 years | 
| Enable initiation interventional studies when appropriate |  | 3 years | 
| Analyse health economy aspects of QoL and morbidity in the patient population |  | 3 years |