Home-based follow-up for testicular cancer patients
Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
This study tests if a home-based follow-up for people who have recently finished treatment for testicular cancer can help them feel better and less anxious compared to regular hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05670938 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a patient-led home-based follow-up approach for individuals treated for testicular cancer. It aims to assess whether this method improves quality of life, reduces anxiety, and lessens fear of cancer recurrence compared to traditional hospital visits. The study focuses on patients who have undergone treatment for testicular cancer within the last three months and will utilize home-based blood sampling to minimize hospital visits and associated distress. The approach is particularly relevant in light of the COVID-19 pandemic, which has limited in-person hospital visits.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older who have been treated for testicular cancer without distant metastasis within the last three months.
Not a fit: Patients with advanced testicular cancer or those who have not completed their initial treatment may not benefit from this home-based follow-up approach.
Why it matters
Potential benefit: If successful, this approach could enhance the well-being of testicular cancer survivors by providing a more comfortable and less anxiety-inducing follow-up experience.
How similar studies have performed: Other studies have indicated that home-based follow-up strategies can improve patient outcomes and satisfaction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed testicular cancer without distant metastasis and treated with curative intent less than 3 months ago: 1\. Non-seminomatous germ cell tumours, stage I low risk: * No lymphadenopathy or metastases on the postoperative scan. * Three consecutive blood drawings with normal tumour markers. * Patients undergoing lymph node dissection as a second curative operation after an orchiectomy, can also be included in case that the postoperative scan shows no residual disease or metastases. 2\. Non-seminomatous germ cell tumours, stage I high risk: * After completion of one cycle of Bleomycin, etoposide and platinum (BEP). * Biochemical remission at completion of chemotherapy, meaning three consecutive blood drawings with normal tumour markers. * No lymphadenopathy or metastases on the CT scan after completion of chemotherapy. 3\. Seminomatous or non-seminomatous germ cell tumours (after chemotherapy) with complete remission. * Biochemical remission at completion of chemotherapy, meaning three consecutive blood drawings with normal tumour markers. * No lymphadenopathy or metastases on the CT scan after completion of chemotherapy. * Scheduled or currently undergoing postoperative surveillance according to national and European guidelines. * Signed informed consent. Exclusion Criteria: * Patients with aberrant levels of LDH preoperatively (LDH \>248 U/L). * Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax * Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent * Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language
Where this trial is running
Rotterdam, South Holland
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dirk J. Grünhagen, MD, PhD — Erasmus Medical Center
- Study coordinator: Lissa Wullaert, MD
- Email: l.wullaert@erasmusmc.nl
- Phone: +316107042125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.