Generalized AnxietyHARMONY-ToolNCT07117058
Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study.
An observational study of Generalized Anxiety and Introspective & Anxiety-Prone Patient, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
Trial summary
In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Generalized Anxiety, Introspective & Anxiety-Prone Patient, Depression, Anxiety
- What is being tested?
- New rapid screening tool for anxiety and depressive disorders, SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) and HADS (Hospital Anxiety and Depression Scale)
- How many people
- 545 participants
- Where
- 7 sitesFrance
- Study dates
- 18 Mar 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with pediatric cancer before the age of 18, whose intensive treatment had ended at least 3 months prior to inclusion and considered to be in complete remission by the doctor responsible for their treatment,
Who may be able to join
- Patients diagnosed with pediatric cancer before the age of 18,
- Patient whose intensive treatment had ended at least 3 months prior to inclusion,
- Patients considered to be in complete remission by the doctor responsible for their treatment,
- Patient affiliated to or entitled under a social security scheme,
- Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.
Who cannot join
- Refusal to participate expressed by the patient or minor,
- Patients whose cancer has relapsed or progressed,
- Pregnant women, women in labor, breast-feeding mothers,
- Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,
- Adults under legal protection (guardianship) or unable to express their consent.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU Angers
Angers, 49933
Stéphanie PROUST, MD, 0241353863 ext. +33, stproust@chu-angers.fr
Stéphanie PROUST, MD
- Not yet recruiting
Centre Hospitalier Universitaire Caen Normandie
Caen, 14033
Marianna DEPARIS, MD, (0)231064488 ext. +33, deparis-m@chu-caen.fr
Marianna DEPARIS, MD
- Not yet recruiting
Centre Hospitalier Universitaire
Grenoble, 38043
ANNE PAGNIER, MD, (0)476765893 ext. +33, anne.pagnier@chu-grenoble.fr
Anne PAGNIER, MD
- Recruiting
IHOPe
Lyon, 69000
AMANDINE BERTRAND-REYNAUD, MD, (0)4 69 16 65 50 ext. +33, amandine.bertrand@lyon.unicancer.fr
Amandine BERTRAND-REYNAUD, MD
- Recruiting
CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2
Nice, 06200
Marilyne POIREE, MD, (0)492039268 ext. +33, poiree.m@chu-nice.fr
Marilyne POIREE, MD
- Not yet recruiting
Centre Hospitalier Universitaire
Rouen, 76000
AUDE MARIE-CARDINE, MD, (0)232880714 ext. +33, aude.marie-cardine@chu-rouen.fr
Aude MARIE-CARDINE, MD
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42000
Sandrine THOUVENIN-DOULET, MD, (0)477828808 ext. +33, sandrine.thouvenin@chu-st-etienne.fr
Claire BERGER, MD
About this study
Official title: Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool
In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.
Read the detailed description
The aim of the HARMONY-Tool study is to develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children, adolescents and young adults cured of childhood cancer.
- Conditions
- Generalized Anxiety, Introspective & Anxiety-Prone Patient, Depression, Anxiety, Survivors of Childhood Cancer
- Being tested
- New rapid screening tool for anxiety and depressive disorders, SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised), HADS (Hospital Anxiety and Depression Scale)
- Keywords
- anxiety symptoms, childhood cancer, screening, psychological complication
- Medical subject headings
- Generalized Anxiety Disorder, Depression, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New rapid screening tool for anxiety and depressive disordersDiagnostic test
New rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation
SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)Diagnostic test
Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old.
HADS (Hospital Anxiety and Depression Scale)Diagnostic test
Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old.
| Study group | Role | What they receive |
|---|---|---|
| 7-10 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children cured of childhood cancer. Receives: Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) | |
| 11-14 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in adolescents cured of childhood cancer. Receives: Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised) | |
| 15-25 years old group | Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in young adults cured of childhood cancer. Receives: Diagnostic Test: New rapid screening tool for anxiety and depressive disorders; Diagnostic Test: HADS (Hospital Anxiety and Depression Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New rapid screening tool for anxiety-depressive disorders
This tools is under construction.
Items development of this tool is following 3 steps :
- Identification of dimensions and generation of items : a combination of a deductive method (literature review) and an inductive method (questioning individuals) are used to identify the various dimensions relevant to the early assessment of anxiety and depressive disorders and generate the corresponding items.
- Content validity : the expert judges method to confirm, supplement, or reduce the initial selection of items are used
- Response options for content validity : binary response options for questions that are unambiguous are used.
This tool will contain a maximum of 7 questions for children aged 6 to 10, 8 questions for adolescents aged 11 to 14 (in particular because of an additional question on the use of addictive substances) and 10 questions for the 15-25 age group (with the possibility of finer dimensions)
Measured: At inclusion
SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
Only for 7-14 years old
Measured: At inclusion
HADS (Hospital Anxiety and Depression Scale)
Only 15-25 years old
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start18 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CLAIRE BERGER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117058
- Sponsor's protocol ID
- 23CH131
- Other IDs
- 2024-A02404-43
- Acronym
- HARMONY-Tool
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Rapid Screening Tool for Anxiety-depressive Disorders in Children, Adolescents and Young Adults Treated in Oncology. Multicenter Study. Short Title: HARMONY-Tool
- ClinicalTrials.gov ID
- NCT07117058
- Acronym / sponsor ID
- HARMONY-Tool / 23CH131
- Conditions
- Generalized Anxiety, Introspective & Anxiety-Prone Patient, Depression, Anxiety, Survivors of Childhood Cancer
- Keywords
- anxiety symptoms, childhood cancer, screening, psychological complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
In France today, it is estimated that one in every 850 people aged between 20 and 45 is a childhood cancer survivor (CCS), equivalent to around 40,000 to 50,000 people. Some descriptive studies have established that the diagnosis and treatment of cancer can affect psychological health. A French study published by our team in 2015 and 2020 showed that in adulthood, 40% of CCS had anxiety symptoms, a rate significantly higher than that of the general French population (25%). However, although there are validated scales for screening children for psychological disorders (anxiety, depression, etc.), there is no rapid screening tool that can be used routinely by an oncologist during consultations. So, the study aims to develop and validate a short test, which could easily be carried out systematically during follow-up consultations after childhood cancer. It would make it possible to identify people with no psychological complications and, conversely, those in whom further investigation, based on the classic reference scales for assessing psychological disorders, would be relevant.
Detailed description
The aim of the HARMONY-Tool study is to develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children, adolescents and young adults cured of childhood cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7-10 years old group | – | Diagnostic Test: New rapid screening tool for anxiety and depressive disorders, Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in children cured of childhood cancer. |
| 11-14 years old group | – | Diagnostic Test: New rapid screening tool for anxiety and depressive disorders, Diagnostic Test: SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in adolescents cured of childhood cancer. |
| 15-25 years old group | – | Diagnostic Test: New rapid screening tool for anxiety and depressive disorders, Diagnostic Test: HADS (Hospital Anxiety and Depression Scale)Develop and validate, using a psychometric method, a rapid screening tool for anxiety-depressive disorders in young adults cured of childhood cancer. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with pediatric cancer before the age of 18, whose intensive treatment had ended at least 3 months prior to inclusion and considered to be in complete remission by the doctor responsible for their treatment,
Key inclusion criteria (5 listed)
- Patients diagnosed with pediatric cancer before the age of 18,
- Patient whose intensive treatment had ended at least 3 months prior to inclusion,
- Patients considered to be in complete remission by the doctor responsible for their treatment,
- Patient affiliated to or entitled under a social security scheme,
- Patient having received informed information about the study OR the holder(s) of parental authority having received informed information about the study in the case of minors.
Key exclusion criteria (5 listed)
- Refusal to participate expressed by the patient or minor,
- Patients whose cancer has relapsed or progressed,
- Pregnant women, women in labor, breast-feeding mothers,
- Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than those of the research,
- Adults under legal protection (guardianship) or unable to express their consent.
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 |
|---|---|---|
| New rapid screening tool for anxiety and depressive disordersNew rapid screening tool for anxiety and depressive disorders completed by patient during a regular follow-up consultation | Diagnostic test | 11-14 years old group, 15-25 years old group, 7-10 years old group |
| SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 7-14 years old. | Diagnostic test | 11-14 years old group, 7-10 years old group |
| HADS (Hospital Anxiety and Depression Scale)Questionnaire completed by patient during a regular follow-up consultation : ONLY for patients 15-25 years old. | Diagnostic test | 15-25 years old group |
Primary outcome
New rapid screening tool for anxiety-depressive disorders
Time frame: At inclusion
This tools is under construction. Items development of this tool is following 3 steps : 1. Identification of dimensions and generation of items : a combination of a deductive method (literature review) and an inductive method (questioning individuals) are used to identify the various dimensions relevant to the early assessment of anxiety and depressive disorders and generate the corresponding items. 2. Content validity : the expert judges method to confirm, supplement, or reduce the initial selection of items are used 3. Response options for content validity : binary response options for questions that are unambiguous are used. This tool will contain a maximum of 7 questions for children aged 6 to 10, 8 questions for adolescents aged 11 to 14 (in particular because of an additional question on the use of addictive substances) and 10 questions for the 15-25 age group (with the possibility of finer dimensions)
SCARED-R-51 (Screen for Child Anxiety Related Emotional Disorders-Revised)
Time frame: At inclusion
Only for 7-14 years old
HADS (Hospital Anxiety and Depression Scale)
Time frame: At inclusion
Only 15-25 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
CLAIRE BERGER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Anxiety and Introspective & Anxiety-Prone Patient, run by Centre Hospitalier Universitaire de Saint Etienne at 7 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLAIRE BERGER, MD ((0)4.77.12.79.37 ext. +33, claire.berger@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New rapid screening tool for anxiety-depressive disorders (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.