NCT03964116

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

November 2, 2018

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Social support on patients psychological adjustment

    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

    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

    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

    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

    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

    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

    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

    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)

    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)

    Describe the grief phenomenon and observe if there are demonstrations of grief when the peer was never met in person (SEC questionnaire).

    4 years

Study Arms (1)

AYA

OTHER

Questionnaires set all 3 months and psychological interviews if needed

Other: Questionnaires set all 3 months

Interventions

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.

Also known as: Psychological interviews
AYA

Eligibility Criteria

Age15 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Leon Berard

Lyon, 69373, France

Location

INSTITUT CURIE - site Paris

Paris, Île-de-France Region, 75005, France

Location

Related Publications (2)

  • Phan J, Vander Haegen M, Karsenti L, Laurence V, Marec-Berard P, Cordero C, Thisse A, Riberon C, Flahault C. Psychological Adjustment, Adaptation, and Perception of Social Support in French Adolescents and Young Adults After the Diagnosis of Cancer. J Adolesc Young Adult Oncol. 2023 Jun;12(3):389-397. doi: 10.1089/jayao.2022.0034. Epub 2022 Sep 6.

    PMID: 36067271BACKGROUND
  • Phan J, Laurence V, Marec-Berard P, Cordero C, Riberon C, Flahault C. The Place of Sick Peers in Adolescents and Young Adults with Cancer: Advantage, Disadvantage, and What Makes Barriers to the Encounter. J Adolesc Young Adult Oncol. 2023 Dec;12(6):879-889. doi: 10.1089/jayao.2022.0176. Epub 2023 Mar 30.

MeSH Terms

Conditions

NeoplasmsAdolescent Behavior

Interventions

Interview, Psychological

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychological TechniquesBehavioral Disciplines and Activities

Study Officials

  • Valérie LAURENCE, MD

    Institut Curie Paris

    PRINCIPAL INVESTIGATOR
  • Cécile FLAHAULT, PhD

    Université René Descartes, Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

May 28, 2019

Study Start

December 7, 2018

Primary Completion

January 25, 2023

Study Completion

January 25, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations