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NCT04389684 Clinical Trial

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

Quality of Life Clinical Trial

— COVIDICA  

Official title:
Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04389684
Other study ID # 2020-A01301-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 27, 2020
Est. completion date November 20, 2020

Study information
Verified date November 2021
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date November 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Psycho-Social Questionnaire
Patients, after enrollmenet in the study, receive a paper questionnaire during the month following COVID19 related confinement and all the material to send it back to the institution. They receive the same questionnaire 3 months later with all the material to send it back to the institution. The intervention is the same for all patients wether their treatment was modified or not.

Locations
Country Name City State
France MOULIN Valérie La Rochelle
France BOURGEOIS Hugues Le Mans
France RANDRIAN Violaine Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer 6 months
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