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OpenTrials
Completed

NCT Number: NCT04389684

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MOULIN Valérie, La Rochelle, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psycho-Social Questionnaire

Other

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.

Primary outcomes

  1. Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: COVIDICA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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