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

30. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

245

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pilot study: quality of questionnaires used
Tidsramme: 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
Tidsramme: 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
Tidsramme: at the end of the study (5 years)
Measured using the CaSUN questionnaire
at the end of the study (5 years)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Efterforskere

  • Ledende efterforsker: Anna Patrikidou, Gustave Roussy, Cancer Campus, Grand Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

4. januar 2027

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2029

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-A00740-51
  • CSET number 2026 / 4327 (Anden identifikator: Gustave Roussy)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Testis Cancer

Kliniske forsøg med Digital tool using extended reality

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