๐ฌIn plain words
What the trial is, and whether it could suit you
The currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after treatment of certain types of testicular cancer.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ 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