- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964116
Impact of Sick Peer Relation on Adaptation to Disease and on Treatment of Cancer-suffering Adolescents & Young Adults (PAIRS-AJA)
Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)
Adolescents and young adults (AYA) with cancer have to deal with a relatively segmented organization of care between pediatric and adult medicine structures in France. However, the third french Plan Cancer 2014-2019 helped in the recognition of the specificities of the AYA affected by cancer and allowed the creation of specific structures in some care units in France, whose primary goal is the preservation of the social link.
Indeed, peer relations contribute to access to quality social support, which is an important variable in patient adjustment with cancer. The adolescents that perceive higher social support report less psychological distress and exhibit higher adaptation scores.
It nevertheless happens that AYA experience negative social support, often from friends because of contact reduction during the disease. Patients can then elect to turn towards non-intimate relations such as support groups. The main risk when a AYA with cancer defines a sick peer as one bringing him quality social support is the installation of a sense of guilt, for example, when a young person is confronted with disease negative progress or with peer death. The more an adolescent identifies with the deceased, the more he is able to consider his own mortality.
AYA units are developing in France, creating a community of sick adolescents. These communities are precious for AYA and allow information and experience sharing, a feeling of reduced isolation and a greater emotional closeness with peers suffering from the same disease.
How is social support from peers and close friends perceived by these young people in AYA units and through the social networks? What can the consequences of the evolution of peer disease be on AYA? What is the impact of the mourning of sick peers on these young people? What are the predictors?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lucille Karsenti, PhD
- Phone Number: 0156245944
- Email: lucille.karsenti@gmail.com
Study Contact Backup
- Name: Souhir Neffati
- Phone Number: 0156245944
- Email: souhir.neffati@curie.fr
Study Locations
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-
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Lyon, France, 69373
- Centre Leon Berard
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Ile De France
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Paris, Ile De France, France, 75005
- INSTITUT CURIE - Site Paris
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents or young adults from 15 to 27 years old (included) receiving cancer diagnose or recurrence announcement.
- Patient information and free consent signature by the patient or his legal representative(s).
Exclusion Criteria:
- Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
- Inability to understand, talk or write in French.
- Patient individually deprived of liberty or placed under the authority of a tutor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: AYA
Questionnaires set all 3 months and psychological interviews if needed
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This longitudinal study based upon repeated and multicentric measurement will recruit AYA with cancer in care Units dedicated to them or not. Measures will be quantitative, and repeated every 3 months by questionnaires, as well as qualitative (social network questionnaire, psychological research interview) for teenagers declaring a negative event or a death event during treatments. Those patients presenting a high depression score will be contacted by a research psychologist for semi-directed interview.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social support on patients psychological adjustment
Time Frame: 4 years
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Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (socio-demographic questionnaire).
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4 years
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Social support on patients psychological adjustment
Time Frame: 4 years
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Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (BDI-II questionnaire).
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4 years
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Social support on patients psychological adjustment
Time Frame: 4 years
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Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (STAI-Y questionnaire).
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4 years
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Psychological adjustment & quality
Time Frame: 4 years
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Compare psychological adjustment in the 2 groups and its quality according to important events (positive or negative) that affect sick peers (STAI-Y questionnaire).
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4 years
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Psychological adjustment & quality
Time Frame: 4 years
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Compare psychological adjustment in the 2 groups and its quality according to important events (positive or negative) that affect sick peers (BDI-II questionnaire).
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4 years
|
Predictors of the grief quality
Time Frame: 4 years
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Define if there are predictors of the grief quality: personality?
Attachment?
Other life events?
Depression?
Nature of the link with dead peers?
(RSQ questionnaire).
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4 years
|
Predictors of the grief quality
Time Frame: 4 years
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Define if there are predictors of the grief quality: personality?
Attachment?
Other life events?
Depression?
Nature of the link with dead peers?
(SSQ6 questionnaire).
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4 years
|
Predictors of the grief quality
Time Frame: 4 years
|
Define if there are predictors of the grief quality: personality?
Attachment?
Other life events?
Depression?
Nature of the link with dead peers?
(BFI-Fr questionnaire).
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4 years
|
Grief phenomenon (real or virtual life)
Time Frame: 4 years
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Describe the grief phenomenon and observe if there are demonstrations of grief when the peer was never met in person (ITG questionnaire).
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4 years
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Grief phenomenon (real or virtual life)
Time Frame: 4 years
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Describe the grief phenomenon and observe if there are demonstrations of grief when the peer was never met in person (SEC questionnaire).
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4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Valérie LAURENCE, MD, Institut Curie Paris
- Study Director: Cécile FLAHAULT, PhD, Université René Descartes, Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IC 2017-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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