Rapid screening for anxiety and depression in children, teens, and young adults treated for cancer
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
This study tests a short questionnaire to quickly find anxiety or depression in children, adolescents, and young adults who were treated for cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 545 (estimated) |
| Ages | 7 Years to 25 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 7 sites (Caen and 6 other locations) |
| Trial ID | NCT07117058 on ClinicalTrials.gov |
What this trial studies
The HARMONY-Tool project is a multicenter observational effort in France to develop and validate a brief screening questionnaire for anxiety-depressive disorders in survivors of childhood cancer using psychometric methods. Eligible participants (diagnosed before age 18 and at least three months after intensive treatment) will complete the new rapid tool alongside established instruments (SCARED-R-51 and HADS). Researchers will analyze reliability, sensitivity, specificity, and optimal cutoffs to determine how well the short instrument identifies cases needing more assessment. The goal is a practical, quick tool oncologists can use routinely during follow-up visits to flag survivors with possible anxiety or depression.
Who should consider this trial
Good fit: Ideal candidates are people diagnosed with cancer before age 18 who are in complete remission, at least three months after intensive treatment, and able to give consent (or whose guardians can consent for minors).
Not a fit: Patients with active relapse or progression, those unable or unwilling to give informed consent, pregnant or breastfeeding women, and adults under legal protection are excluded and unlikely to benefit from this screening.
Why it matters
Potential benefit: If successful, the tool could help oncologists quickly identify survivors who need further psychological care during routine follow-up.
How similar studies have performed: Validated instruments such as SCARED-R-51 and HADS have been used to detect anxiety and depression and prior French work has shown high anxiety rates in childhood cancer survivors, but applying and validating a very brief routine screening tool is a more novel effort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. Exclusion Criteria * 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.
Where this trial is running
Caen and 6 other locations
- Centre Hospitalier Universitaire Caen Normandie — Caen, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire — Grenoble, France (Not_yet_recruiting)
- Ihop — Lyon, France (Recruiting)
- CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2 — Nice, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire — Rouen, France (Not_yet_recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
- Hopitaux Universitaires de Strasbourg, Hopital Hautepierre — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Claire Berger, Md — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Claire Berger, Md
- Email: claire.berger@chu-st-etienne.fr
- Phone: (0)4.77.12.79.37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.