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Impact of Sick Peer Relation on Adaptation to Disease and on Treatment of Cancer-suffering Adolescents & Young Adults (PAIRS-AJA)

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ClinicalTrials.gov Identifier: NCT03964116
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Institut Curie

Brief Summary:

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?


Condition or disease Intervention/treatment Phase
Cancer Adolescent Behavior Young Adult Other: Questionnaires set all 3 months Not Applicable

Detailed Description:
Methodology: Multicentric, prospective, not randomized study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
AYA
Questionnaires set all 3 months and psychological interviews if needed
Other: Questionnaires set all 3 months

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 Name: Psychological interviews




Primary Outcome Measures :
  1. Social support on patients psychological adjustment [ Time Frame: 4 years ]
    Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (socio-demographic questionnaire).

  2. Social support on patients psychological adjustment [ Time Frame: 4 years ]
    Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (BDI-II questionnaire).

  3. Social support on patients psychological adjustment [ Time Frame: 4 years ]
    Compare the social support received and its effects on psychological adjustment in AYA unit groups versus groups without AYA unit (STAI-Y questionnaire).

  4. Psychological adjustment & quality [ Time Frame: 4 years ]
    Compare psychological adjustment in the 2 groups and its quality according to important events (positive or negative) that affect sick peers (STAI-Y questionnaire).

  5. Psychological adjustment & quality [ Time Frame: 4 years ]
    Compare psychological adjustment in the 2 groups and its quality according to important events (positive or negative) that affect sick peers (BDI-II questionnaire).

  6. 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? (RSQ questionnaire).

  7. 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? (SSQ6 questionnaire).

  8. 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).

  9. Grief phenomenon (real or virtual life) [ Time Frame: 4 years ]
    Describe the grief phenomenon and observe if there are demonstrations of grief when the peer was never met in person (ITG questionnaire).

  10. Grief phenomenon (real or virtual life) [ Time Frame: 4 years ]
    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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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adolescents or young adults from 15 to 25 years old receiving cancer diagnose or recurrence announcement.
  2. Patient information and free consent signature by the patient or his legal representative(s).

Exclusion Criteria:

  1. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
  2. Inability to understand, talk or write in French.
  3. Patient individually deprived of liberty or placed under the authority of a tutor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964116


Contacts
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Contact: Lucille Karsenti, PhD 0156245944 lucille.karsenti@gmail.com
Contact: Souhir Neffati 0156245944 souhir.neffati@curie.fr

Locations
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France
INSTITUT CURIE - site Paris Recruiting
Paris, Ile De France, France, 75005
Contact: Valérie LAURENCE, MD    +33(0)1 44 32 42 07    valerie.laurence@curie.fr   
Principal Investigator: Valérie LAURENCE, MD         
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Perrine MAREC-BERARD, MD    +33 (0)478782642    perrine.marec-berard@ihope.fr   
Principal Investigator: Perrine MAREC-BERARD, MD         
Sponsors and Collaborators
Institut Curie
University of Paris 5 - Rene Descartes
Investigators
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Principal Investigator: Valérie LAURENCE, MD Institut Curie Paris
Study Director: Cécile FLAHAULT, PhD Université René Descartes, Paris
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03964116    
Other Study ID Numbers: IC 2017-10
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms