Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

NCT04366154 | Unknown

• 1 other identifier: 2020-A00879-30
• Study Type: observational
• Target: 809
• Locations: 1 country
• Sites: 2

Brief Summary

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers

Conditions

COVID-19; Cancer

Outcome Measures

Primary Outcomes (4)

• To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy

  Proportion of patients with modification of the treatments administered

  up to 6 months

• To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy

  Proportion of patients with change in the rate of treatment administration

  up to 6 months

• To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy

  Proportion of patients with change in the number of cures administered

  up to 6 months

• To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy

  Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

  up to 6 months

Secondary Outcomes (9)

• Evaluate the perceived stress on cancer patients treated in unit day of hospital

  up to 12 months

• Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital

  up to 12 months

• Evaluate the sleep disorders on cancer patients treated in unit day of hospital

  up to 12 months

• Evaluate the quality of life on cancer patients treated in unit day of hospital

  up to 12 months

• Evaluate the cognitive complaints on cancer patients treated in unit day of hospital

  up to 12 months

Study Arms (2)

Patients

Other: Questionnaire

Caregivers

Other: Questionnaire

Interventions

Questionnaire OTHER

delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint

Caregivers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

2 populations were recruted in this study : patients with cancer and caregivers

You may qualify if:

• For Patients:
• Adult patient, treated for a solid or hematological tumor
• will be treated ou actually treated by oncological treatment carried out at the hospital in day unit of the participating centers: treatment initiated before or during the pandemic with COVID-19
• For the Caregivers:
• \- Medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (2)

Centre François Baclesse

Caen, France

Location

Centre Henri Becquerel

Rouen, France

Location

Related Publications (2)

• Cherifi F, Gernier F, Jardin F, Lefevre-Arbogast S, Bastien E, Lequesne J, Rigal O, Quilan F, Clarisse B, Grellard JM, Binarelli G, Fernette M, Lange M, Richard D, Morel A, Griffon B, Pepin LF, Leconte A, Faveyrial A, Leheurteur M, Beauplet B, Joly F. Post-traumatic stress disorder symptoms and quality of life among older patients with cancer during the COVID-19 pandemic. J Geriatr Oncol. 2023 Nov;14(8):101634. doi: 10.1016/j.jgo.2023.101634. Epub 2023 Sep 25.

  PMID: 37757587 DERIVED

• Bastien E, Lefevre-Arbogast S, Lequesne J, Gernier F, Cherifi F, Rigal O, Guittet L, Grellard JM, Binarelli G, Lange M, Fernette M, Tron L, Morel A, Richard D, Griffon B, Leconte A, Quilan F, Pepin LF, Jardin F, Leheurteur M, Faveyrial A, Clarisse B, Joly F. Posttraumatic Stress Symptoms in Patients With Cancer During the COVID-19 Pandemic: A One-Year Longitudinal Study. J Natl Compr Canc Netw. 2023 Feb 22;21(3):265-272.e7. doi: 10.6004/jnccn.2023.7085.

  PMID: 36812938 DERIVED

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 28, 2020
• Study Start: April 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: May 1, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)