QoLiCOL - Quality of Life in Colon Cancer
- Conditions
- Colonic Neoplasm
- Interventions
- Behavioral: There is no intervention, only observation
- Registration Number
- NCT02530593
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- Brief 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)
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Colon cancer newly diagnosed.
- Planned treatment presented
- No Colon cancer diagnosis,
- below 18 years of age,
- no informed consent or withdrawn informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with colon cancer There is no intervention, only observation All patients presenting with a newly diagnosed colon cancer regardless of tumour stage
- Primary Outcome Measures
Name Time Method QoL in colon cancer patients 3 years The primary end-point is to describe QoL, symptoms and functional impairments in an unselected population of colon cancer patients
- Secondary Outcome Measures
Name Time Method 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 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 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 health economy aspects of QoL and morbidity in the patient population 3 years
Trial Locations
- Locations (1)
Sahlgrenska University Hospital/Östra
🇸🇪Göteborg, Sweden