Clinical trial NCT02530593: QoLiCOL - Quality of Life in Colon Cancer
Official title: QoLiCOL - Quality of Life in Colon Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colonic Neoplasm
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colon cancer prior to treatment initiation.

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.

Eligibility criteria: 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* no informed consent or withdrawn informed consent.

Primary outcomes:
measure: QoL in colon cancer patients
timeFrame: 3 years
Secondary outcomes:
measure: Generate basic descriptive data of the patient population, such as demography, socioeconomic data, disease stage at diagnosis, type of treatment, recurrence and survival
timeFrame: 3 years
measure: Compare differences in QoL between patients with different tumour levels
timeFrame: 3 years
measure: Detect differences in QoL in patients over time after colon cancer treatment
timeFrame: 3 years
measure: Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation
timeFrame: 3 years
measure: Evaluate the effect of coping strategies on QoL after initiated treatment
timeFrame: 3 years
measure: Describe patient expectations at diagnosis of colon cancer
timeFrame: 3 years
measure: Identify differences in QoL between patients in different groups regarding gender, age and education level
timeFrame: 3 years
measure: Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL
timeFrame: 3 years
measure: Identify areas of improvement in treatment and patient care
timeFrame: 3 years
measure: Enable initiation interventional studies when appropriate
timeFrame: 3 years
measure: Analyse health economy aspects of QoL and morbidity in the patient population
timeFrame: 3 years
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital/Östra
Study officials:
affiliation: SSORG
name: Eva Angenete, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: