QoLiCOL - Quality of Life in Colon Cancer (QoLiCOL)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Colonic Neoplasm
• Intervention / Treatment: Behavioral: There is no intervention, only observation

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 416 85
    • Sahlgrenska University Hospital/Östra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with colon cancer prior to treatment initiation.

Description

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• no informed consent or withdrawn informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with colon cancer; All patients presenting with a newly diagnosed colon cancer regardless of tumour stage	Behavioral: There is no intervention, only observation

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Eva Angenete, M.D., Ph.D., SSORG

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2022
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimated): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: QoLiCOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED