Cancer Clinical Trial
— COVID-TRAUMAOfficial title:
COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Verified date | July 2021 |
Source | Institut Paoli-Calmettes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence. It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later. Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.
Status | Completed |
Enrollment | 1096 |
Est. completion date | February 2, 2021 |
Est. primary completion date | November 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Man or woman, age>18 - Diagnosis of cancer (solid tumor or hematology) - Out patient or patient Under surveillance Exclusion Criteria: - Refusal to participate in the study - Emergency, person deprived of liberty - hospitalized patient |
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli-Calmettes | Marseille |
Lead Sponsor | Collaborator |
---|---|
Institut Paoli-Calmettes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of the Impact of Event Scale Revisited scale | at inclusion and 6 months later | ||
Secondary | Factors associated with post-traumatic stress disorder | The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale | at inclusion and 6 months later | |
Secondary | Measure of the patient's anxiety | The measure of anxiety, measured by the State-Trait Anxiety Questionnaire | at inclusion and 6 months later | |
Secondary | proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic. | at inclusion and 6 months later | ||
Secondary | proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19 | at inclusion and 6 months later | ||
Secondary | proportion of patients stating that remote consultation is as useful as a face-to-face consultation | at inclusion and 6 months later | ||
Secondary | proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone) | at inclusion and 6 months later | ||
Secondary | Score on the cancer recurrence scale | at inclusion and 6 months later |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|