CancerPAIRS-AJANCT03964116
Impact of Sick Peer Relation on Adaptation to Disease and on Treatment of Cancer-suffering Adolescents & Young Adults
A study testing Questionnaires set all 3 months in people with Cancer and Adolescent Behavior, run by Institut Curie at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 15 to 27 years
- Conditions the study is for
- Cancer, Adolescent Behavior, Young Adult
- What is being tested?
- Questionnaires set all 3 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Dec 2018to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Leon Berard
Lyon, 69373
INSTITUT CURIE - site Paris
Paris, Île-de-France Region, 75005
About this study
Official title: 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.
Read more
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?
Read the detailed description
Methodology: Multicentric, prospective, not randomized study.
- Conditions
- Cancer, Adolescent Behavior, Young Adult
- Being tested
- Questionnaires set all 3 months
- Medical subject headings
- Neoplasms, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires set all 3 monthsOther
Also called Psychological interviews
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.
| Study group | Role | What they receive |
|---|---|---|
| AYA | Other | Questionnaires set all 3 months and psychological interviews if needed Receives: Other: Questionnaires set all 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start7 Dec 2018
- Primary completion25 Jan 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Valérie LAURENCE, MD, Principal investigator, Institut Curie ParisCécile FLAHAULT, PhD, Study director, Université René Descartes, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964116
- Sponsor's protocol ID
- IC 2017-10
- Acronym
- PAIRS-AJA
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2018
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36067271Phan 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.
PubMed 36999900
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)
- ClinicalTrials.gov ID
- NCT03964116
- Acronym / sponsor ID
- PAIRS-AJA / IC 2017-10
- Conditions
- Cancer, Adolescent Behavior, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Methodology: Multicentric, prospective, not randomized study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA | Other | Other: Questionnaires set all 3 monthsQuestionnaires set all 3 months and psychological interviews if needed |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires set all 3 monthsAlso: Psychological interviewsThis 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 | AYA |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 36067271Phan 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.
- Results publication: PubMed 36999900Phan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie LAURENCE, MD principal investigator
Institut Curie Paris
Cécile FLAHAULT, PhD study director
Université René Descartes, Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires set all 3 months in people with Cancer and Adolescent Behavior, run by Institut Curie at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social support on patients psychological adjustment (time frame: 4 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.