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Helping Young People With Testicular Cancer Using Virtual and Extended Reality (TRANSCEND-XR)

30 aprile 2026 aggiornato da: Gustave Roussy, Cancer Campus, Grand Paris

Addressing TesticulaR cANcer Unmet Supportive CarE NeeDs in Adolescents and Young Adults Using eXtended Reality

TRANSCEND-XR is a European research project designed to better support adolescents and young adults who have been cured of testicular cancer. Even after treatment has ended, many young people continue to face physical, psychological, or social difficulties that are often poorly understood and insufficiently addressed.

The project aims to develop an innovative digital tool using extended reality (XR) to help these young people better understand the potential long-term effects of the disease and its treatments, recognize signs that require medical attention, and become more active participants in their own health follow-up.

TRANSCEND-XR first includes a pilot phase to test feasibility and improve the tool, followed by a larger clinical study comparing its use with usual medical follow-up. Researchers will assess, in particular, its impact on patients' knowledge, quality of life, and ability to seek help.

The ultimate goal is to sustainably improve information, autonomy, and well-being among young survivors of testicular cancer through a digital approach tailored to their needs and daily practices.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Testicular cancer is a rare cancer, but it mainly affects adolescents and young adults. Today, thanks to the effectiveness of treatments, the vast majority of patients are cured. However, even after treatment has ended, many young people continue to live with long-term consequences, known as "late effects." These effects can vary widely and may include persistent fatigue, pain, hormonal or sexual problems, psychological difficulties such as anxiety or stress, as well as impacts on social life, relationships, education, or professional life.

These difficulties are often poorly understood by patients themselves, sometimes insufficiently addressed during medical follow-up, and may last for several years. Many young people feel inadequately informed, isolated, or unsure about when and how to seek help. Although essential, standard medical follow-up does not always fully address all of these supportive care needs.

It is within this context that the TRANSCEND-XR project was created. TRANSCEND-XR is a European research project coordinated by Gustave Roussy, aiming to develop and evaluate an innovative digital tool based on extended reality (XR) for adolescents and young adults treated for testicular cancer.

TRANSCEND-XR seeks to help young survivors better understand their disease and the treatments they have received, learn about potential long-term effects, recognize symptoms that require medical attention, and adopt health-promoting behaviors. The tool also aims to strengthen their autonomy, confidence, and ability to take an active role in their own follow-up care.

The project is carried out in two main phases. A first pilot study, conducted with a small number of participants across several countries, assesses the feasibility, usability, and acceptability of the tool and allows it to be improved based on patient feedback. A second phase involves a larger clinical study comparing young people who use the TRANSCEND-XR tool with others who receive standard follow-up care only. Researchers will evaluate, in particular, the impact on patients' knowledge, quality of life, supportive care needs, help-seeking behavior, and engagement in long-term follow-up.

Beyond medical outcomes, TRANSCEND-XR also focuses on user experience, digital accessibility, ethical considerations, and equity, in order to offer a solution that is truly adapted to young people's needs and everyday practices.

In summary, TRANSCEND-XR aims to sustainably improve information, well-being, and quality of life for young survivors of testicular cancer, using innovative digital tools to better address the challenges of life after cancer.

Tipo di studio

Interventistico

Iscrizione (Stimato)

245

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Any person assigned male at birth who is diagnosed with stage I-III TC (germ cell tumour of the testicles).
  2. Aged between 15 and 39 years at the time of study inclusion.
  3. Completed curative treatment comprising of at least one standard treatment modality (surgery, chemotherapy and/or radiotherapy) for treatment of their cancer. A maximum of 9 months from the end of curative treatment will be allowed.

  4. Permitted treatment modalities:

    • Localised disease: orchiectomy with or without chemotherapy and/or radiotherapy.
    • Metastatic disease: orchiectomy and chemotherapy or radiotherapy or retroperitoneal surgery, or a combination of aforementioned treatments. First-line treatment only allowed.
  5. Willing and able to provide a valid and signed informed consent and/or assent, as appropriate.
  6. ECOG performance status 0-2.
  7. Patients accept to use personal smartphone
  8. Patients able to read and understand the local language

Exclusion Criteria:

  1. Non-testicular germ cell tumours (e.g., mediastinal primary or retroperitoneal primary tumours).
  2. Non-germ cell TC.
  3. Previous chemotherapy, radiotherapy, or surgery for TC other than that allowed in IC 4.
  4. History of contralateral TC.
  5. Any illness that would prevent the AYA TC survivor from giving a valid and signed informed consent, as assessed by the investigator.
  6. Any illness that might be exacerbated by the use of an XR digital tool, as assessed by the investigator, including history of severe motion sickness, brain lesions and epilepsy.
  7. Uncontrolled medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease (including but not limited to grade 2 or higher cardiac failure, arrythmia, unstable angina, history of myocardial infract in the 6 months which, in the opinion of the treating physician, would influence the assessment of long-term side effect of TC treatment.
  8. AYA TC survivors with a "currently active" second malignancy other than non-melanoma skin cancers, superficial non-invasive (pTa or pTis) TCC of the bladder, or intratubular germ cell neoplasia. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
  9. Chemotherapy or radiotherapy for malignant disease other than TC within the past 3 years.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention arm (arm I)
participants will receive, in addition to their standard of care, an educational intervention via the digital tool for a period of 6 months, followed by an additional 12 months of follow-up.
Altro: Digital tool using extended reality

TRANSCEND-XR is a digital educational intervention based on extended reality (XR), designed for adolescents and young adults who have completed curative treatment for testicular cancer.

It provides interactive and immersive content aimed at improving understanding of the late effects of treatment, whether physical, psychological, or social. The tool helps users recognize symptoms that require medical attention, strengthen their health knowledge, and adopt behaviors that support long-term follow-up, such as self-examination and appropriate use of healthcare services.

Co-designed with patients and healthcare professionals, TRANSCEND-XR aims to enhance autonomy, confidence, and engagement of young survivors in managing their health after cancer.
Nessun intervento: Control arm (arm C)
participants will receive their standard of care, without intervention, for a period of 6 months, followed by an additional 12 months of follow-up.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer
Lasso di tempo: after 6 months of inclusion
Assessed by inclusion time, engagement, no major issue with patient feedback
after 6 months of inclusion
pRCT (Pragmatic Randomized Controlled Trial): knowledge of the late effects of XR digital tool in AYA survivors of testicular cancer
Lasso di tempo: 12 months follow-up (18 months after randomization)
Assessed by analysis of data collected during study visits
12 months follow-up (18 months after randomization)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pilot study: quality of questionnaires used
Lasso di tempo: 9 months after the begin of the study
Assessed by completion rate and number of missing responses
9 months after the begin of the study
pRCT (Pragmatic Randomized Controlled Trial): Health-related quality of life
Lasso di tempo: at the end of the study (5 years)
Assessed using the EORTC-QLQ-C30 & T26 and EQ-5D-5L questionnaires
at the end of the study (5 years)
pRCT (Pragmatic Randomized Controlled Trial): Supportive care needs
Lasso di tempo: at the end of the study (5 years)
Measured using the CaSUN questionnaire
at the end of the study (5 years)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigatori

  • Investigatore principale: Anna Patrikidou, Gustave Roussy, Cancer Campus, Grand Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

4 gennaio 2027

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 giugno 2029

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-A00740-51
  • CSET number 2026 / 4327 (Altro identificatore: Gustave Roussy)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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