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

December 1, 2023 updated by: Institut Curie

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

Active, not recruiting

Detailed Description

Methodology: Multicentric, prospective, not randomized study.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Lyon, France, 69373
        • Centre Leon Berard
    • Ile De France
      • Paris, Ile De France, France, 75005
        • INSTITUT CURIE - Site Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adolescents or young adults from 15 to 27 years old (included) 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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:
  • Psychological interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 years
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).
4 years
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 years
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).
4 years
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).
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? (RSQ questionnaire).
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? (SSQ6 questionnaire).
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).
4 years
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).
4 years
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).
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Valérie LAURENCE, MD, Institut Curie Paris
  • Study Director: Cécile FLAHAULT, PhD, Université René Descartes, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Actual)

January 25, 2023

Study Completion (Estimated)

January 25, 2024

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

November 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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