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

NCT ID: NCT04389684

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-27

Study Completion Date

2020-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Chemeotherapy Immunotherapy Treatment Mofidied Coronavirus Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MOULIN Valérie

La Rochelle, , France

Site Status

BOURGEOIS Hugues

Le Mans, , France

Site Status

RANDRIAN Violaine

Poitiers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40045328 (View on PubMed)

Other Identifiers

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2020-A01301-38

Identifier Type: -

Identifier Source: org_study_id