QoLiCOL - Quality of Life in Colon Cancer

NCT ID: NCT02530593

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2025-09-30

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.

Conditions

Colonic Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with colon cancer

All patients presenting with a newly diagnosed colon cancer regardless of tumour stage

There is no intervention, only observation

Intervention Type: BEHAVIORAL

Interventions

There is no intervention, only observation

Intervention Type: BEHAVIORAL

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• no informed consent or withdrawn informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva Angenete

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Angenete, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SSORG

Locations

Sahlgrenska University Hospital/Östra

Gothenburg, , Sweden

Countries

Sweden

References

Sandberg SJ, Park JM, Tasselius VA, Angenete E. Bowel Dysfunction After Colon Cancer Surgery: A Prospective, Longitudinal, Multicenter Study. Dis Colon Rectum. 2024 Oct 1;67(10):1322-1331. doi: 10.1097/DCR.0000000000003358. Epub 2024 Jun 20.

Reference Type: DERIVED

PMID: 38902840 (View on PubMed)

Ehrencrona C, Li Y, Angenete E, Haglind E, Franzen S, Grimby-Ekman A, Bock D. Do beta-blockers reduce negative intrusive thoughts and anxiety in cancer survivors? - An emulated trial. BMC Cancer. 2024 Apr 11;24(1):447. doi: 10.1186/s12885-024-12236-3.

Reference Type: DERIVED

PMID: 38605350 (View on PubMed)

Other Identifiers

QoLiCOL

Identifier Type: -

Identifier Source: org_study_id