Last update : 05/03/2021 | Version : 1 | ID : 73967
| General | |
| Identification | |
| Detailed name | Psychological management of patients in the oncology context, presenting post-traumatic stress disorder in the context of the COVID-19 epidemic |
| Sign or acronym | COVIPACT 2 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
Yes |
| Health determinants |
Others (specify) |
| Others (details) | Post-traumatic stress |
| Scientific investigator(s) (Contact) | |
| Name of the director | NARAYANASSAMY |
| Surname | Antony |
| Address | Centre François Baclesse<br>3 avenue du Général Harris<br>14076 CAEN cedex 5<br> |
| Phone | 02 31 45 50 50 |
| a.narayanassamy@baclesse.unicancer.fr | |
| Organization | François Baclesse Centre |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Details | François Baclesse Centre |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | François Baclesse Centre |
| Organisation status |
Private |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Name of the contact | GRELLARD |
| Surname | Jean-Michel |
| Address | Centre François Baclesse<br>3 avenue du Général Harris<br>14076 CAEN cedex 5<br> |
| Phone | 02 31 45 50 50 |
| jm.grellard@baclesse.unicancer.fr | |
| Organization | François Baclesse Centre |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Specify | Level 2 interventional human research |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Database objective | |
| Main objective | Evaluate the value of psychological management in patients with confirmed post-traumatic stress disorder (PTSD) related to the COVID-19 epidemic, in terms of the improvement in stress. |
| Inclusion criteria |
- Patient ≥ 18 years
- Patient treated or followed up for a solid tumour at the François Baclesse Cancer Centre - Patient with a high post-traumatic stress disorder score (score ≥ 33 on the IES-R scale) related to the COVID-19 epidemic - Patient state of health compatible with implementation of the programme: psychological management for 6 months - Information leaflet signed by the patient - Any associated geographical, social or psychopathological condition liable to compromise the patient’s ability to take part in the study |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | II - Neoplasms |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Normandie |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2021 |
| Date of last collection (YYYY or MM/YYYY) | 2021 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Procedures | |
| Data collection method | Entry in an eCRF |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05