Addressing TesticulaR cANcer Unmet Supportive CarE NeeDs in Adolescents and Young Adults Using eXtended Reality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 245
- 主要终点
- Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Willing and able to provide a valid and signed informed consent and/or assent, as appropriate.
- •ECOG performance status 0-
- •Patients accept to use personal smartphone
- •Patients able to read and understand the local language
排除标准
- •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
- •History of contralateral TC.
- •Any illness that would prevent the AYA TC survivor from giving a valid and signed informed consent, as assessed by the investigator.
- •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.
- •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.
- •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.
- •Chemotherapy or radiotherapy for malignant disease other than TC within the past 3 years.
研究组 & 干预措施
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.
干预措施: Digital tool using extended reality (Other)
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.
结局指标
主要结局
Pilot study: to determine the feasibility of implementing the XR digital tool in AYA survivors of testicular cancer
时间窗: after 6 months of inclusion
Assessed by inclusion time, engagement, no major issue with patient feedback
pRCT (Pragmatic Randomized Controlled Trial): knowledge of the late effects of XR digital tool in AYA survivors of testicular cancer
时间窗: 12 months follow-up (18 months after randomization)
Assessed by analysis of data collected during study visits
次要结局
- Pilot study: quality of questionnaires used(9 months after the begin of the study)
- pRCT (Pragmatic Randomized Controlled Trial): Health-related quality of life(at the end of the study (5 years))
- pRCT (Pragmatic Randomized Controlled Trial): Supportive care needs(at the end of the study (5 years))