NCT02530593

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

7.4 years

First QC Date

August 19, 2015

Last Update Submit

November 3, 2023

Conditions

Colonic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

Patients with colon cancer

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

Behavioral: There is no intervention, only observation

Interventions

There is no intervention, only observationBEHAVIORAL
Patients with colon cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with colon cancer prior to treatment initiation.

You may qualify if:

  • Colon cancer newly diagnosed.
  • Planned treatment presented

You may not qualify if:

  • No Colon cancer diagnosis,
  • below 18 years of age,
  • no informed consent or withdrawn informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, 416 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 38902840DERIVED

  • 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.

    PMID: 38605350DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Eva Angenete, M.D., Ph.D.

    SSORG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 21, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2022

Study Completion

September 1, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

SE(1)