Helping Young People With Testicular Cancer Using Virtual and Extended Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age15-39
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any person assigned male at birth who is diagnosed with stage I-III TC (germ cell tumour of the testicles).
Aged between 15 and 39 years at the time of study inclusion.
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.
Localised disease: orchiectomy with or without chemotherapy and/or radiotherapy.
Disqualifiers
Non-testicular germ cell tumours (e.g., mediastinal primary or retroperitoneal primary tumours).
Non-germ cell TC.
Previous chemotherapy, radiotherapy, or surgery for TC other than that allowed in IC 4.
History of contralateral TC.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital tool using extended reality
Other interventionTRANSCEND-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.
Treatment groups
245 Participants
are divided into 2 treatment groupsGroup A: Intervention arm (arm I)Experimental treatment 1 intervention
Group B: Control arm (arm C)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer
Assessed by inclusion time, engagement, no major issue with patient feedback
Time frame
after 6 months of inclusion2
pRCT (Pragmatic Randomized Controlled Trial): knowledge of the late effects of XR digital tool in AYA survivors of testicular cancer
Assessed by analysis of data collected during study visits
Time frame
12 months follow-up (18 months after randomization)Secondary outcomes
1
Pilot study: quality of questionnaires used
Assessed by completion rate and number of missing responses
Time frame
9 months after the begin of the study2
pRCT (Pragmatic Randomized Controlled Trial): Health-related quality of life
Assessed using the EORTC-QLQ-C30 \& T26 and EQ-5D-5L questionnaires
Time frame
at the end of the study (5 years)3
pRCT (Pragmatic Randomized Controlled Trial): Supportive care needs
Measured using the CaSUN questionnaire
Time frame
at the end of the study (5 years)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: