COVIDICA: Clinical and Psycho-social Impact of COVID-19 Related Confinement on Patients With Digestive Tumors

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04389684
Collaborator
(none)
102
3
5.8
34
5.8

Study Details

Study Description

Brief Summary

To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Psycho-Social Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
102 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France
Actual Study Start Date :
May 27, 2020
Actual Primary Completion Date :
Nov 20, 2020
Actual Study Completion Date :
Nov 20, 2020

Outcome Measures

Primary Outcome Measures

  1. Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Histologically proven digestive tumor

  • Ongoing treatment from March,1st and April 30th

Exclusion Criteria:
  • Patient refusal for enrollment in the study

  • Patient not recognised legally competent

Contacts and Locations

Locations

Site City State Country Postal Code
1 MOULIN Valérie La Rochelle France
2 BOURGEOIS Hugues Le Mans France
3 RANDRIAN Violaine Poitiers France

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT04389684
Other Study ID Numbers:
  • 2020-A01301-38
First Posted:
May 15, 2020
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 29, 2021