Clinical trial Recruiting at 4 sites Observational Ages 7 to 25

Rapid screening for anxiety and depression in children, teens, and young adults treated for cancer

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

Run by Centre Hospitalier Universitaire de Saint Etienne · NCT07117058 · Data updated 2026-11-12

This study tests a short questionnaire to quickly find anxiety or depression in children, adolescents, and young adults who were treated for cancer.

More Depression, Anxiety trials

Quick facts

Study typeObservational
Ages7 Years to 25 Years
SexAll
Enrollment545 (estimated)
SponsorCentre Hospitalier Universitaire de Saint Etienne
Academic / other
Locations7 sites (Angers and 6 other locations)
StatusRecruiting
StartedMarch 18, 2025
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedJuly 31, 2026
Trial IDNCT07117058 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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).

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU Angers
    Angers, France
    Recruiting
  • IHOPe
    Lyon, France
    Recruiting
  • CENTRE HOSPITALIER UNIVERSAIRE DE NICE - Hôpital Archet 2
    Nice, France
    Recruiting
  • CHU de Saint-Etienne
    Saint-Etienne, France
    Recruiting
  • Centre Hospitalier Universitaire Caen Normandie
    Caen, France
    Not yet recruiting
  • Centre Hospitalier Universitaire
    Grenoble, France
    Not yet recruiting
Show 1 more location
  • Centre Hospitalier Universitaire
    Rouen, France
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.