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

Cancer Clinical Trial

— PAIRS-AJA  

Official title:

Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964116
• Other study ID #: IC 2017-10
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: January 25, 2024

Study information

• Verified date: November 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Methodology: Multicentric, prospective, not randomized study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Cancer
• Young Adult

Intervention

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.

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	INSTITUT CURIE - site Paris	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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