The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer (CovidRC)

An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival

Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.

The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Diagnosed during or not during the pandemic

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Anette Wedin, RN; Email: anette.wedin@vgregion.se
• Study Contact Backup: Name: Eva Angenete, MD. PhD; Phone Number: 0760514441; Email: eva.angenete@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, SE 416 85
    • Recruiting
    • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
    • Contact: Anette Wedin, RN
    • Contact: Eva Angenete, MD,PhD; Phone Number: +46313438410; Email: eva.angenete@vgregion.se

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.

Description

Inclusion Criteria:

• Rectal cancer diagnosis 2019-2022

Exclusion Criteria:

• No rectal cancer diagnosis 2019-2022

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed before, during or after the pandemic; Patients with rectal cancer	Other: Diagnosed during or not during the pandemic; We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yearly incidence of rectal cancer	The number of patients diagnosed yearly 2019, 2020, 2021 and 2022	2019-2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms at diagnosis	Symptoms at diagnosis as reported by patients	6 months prior diagnosis
Patient's delay	Delay from symptoms until doctors appointment	12 months prior diagnosis
Doctor's delay	Delay from doctor's appointment until diagnosis	12 months prior diagnosis
Treatment changes	Any changes from the treatment plan due to covid-19	Diagnosis and 12 months following

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 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; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CovidRC

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No