Clinical and Psycho-social Impact of COVID-19 Related Confinement on Patients With Digestive Tumors
COVIDICA
Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France
1 other identifier
observational
102
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2020
CompletedNovember 29, 2021
November 1, 2021
6 months
May 14, 2020
November 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer
6 months
Interventions
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.
Eligibility Criteria
Patients under chemotherapy, immunotherapy or targeted therapy for a digestive tumor had their treatment modified during Coronavirus epidemia in France.
You may qualify if:
- Histologically proven digestive tumor
- Ongoing treatment from March,1st and April 30th
You may not qualify if:
- Patient refusal for enrollment in the study
- Patient not recognised legally competent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
MOULIN Valérie
La Rochelle, France
BOURGEOIS Hugues
Le Mans, France
RANDRIAN Violaine
Poitiers, France
Related Publications (1)
Randrian V, Dhimene A, Pillet A, Evrard C, Elfadel R, Boyer C, Guyot d'Asnieres de Salins A, Ingrand I, Ferru A, Rouleau L, Tougeron D. COVID-19 lockdown-related treatment modifications did not impact the outcome of digestive cancers: the Clin-COVIDICA prospective study. BMC Cancer. 2025 Mar 5;25(1):398. doi: 10.1186/s12885-025-13787-9.
PMID: 40045328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 15, 2020
Study Start
May 27, 2020
Primary Completion
November 20, 2020
Study Completion
November 20, 2020
Last Updated
November 29, 2021
Record last verified: 2021-11