Testicular cancer testicular tumor
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 18 years. • Histologically confirmed testicular cancer without distant metastasis and treated with curative intent less than 6 months ago: o 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. o Non-seminomatous germ cell tumours, stage I high risk, and combined tumors: * 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. o 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
Exclusion criteria: • Patients with aberrant levels of LDH preoperatively (LDH >248 U/L). • Patients with a severely complicated postoperative course, needing in hospital follow-up longer than 6 months postoperatively • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the successful implementation of home-based tumor marker measurements with a lancing kit. Successful implementation of the home-based aspect is defined as 25% or more of all tumor marker measurements actually being performed at home by the patients themselves. The idea is that if less than 25% of possible home-based measurements are utilized, the added value of giving the patient the choice to perform home-based measurements is minimal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study will be: * To implement a patient-led home-based follow-up approach in patients treated for testicular cancer. A successful implementation of the patient-led aspect is defined as 75% or less of optional follow-up moments utilised in the follow-up scheme of patients treated for non-seminoma, stage 1 low risk. * Quality of life: measured by the QLQ-C30 (Appendix D) * Health-related quality of life and the QLQ-TC26 (Appendix E) * Momentary quality of life: measured by ecological momentary assessment using the Global health status of the EORTC QLQ-C30 (Appendix F) * Anxiety: measured by The State-Trait Anxiety Inventory: Six-Item Short-form (STAI-6) (Appendix G) * Fear of cancer recurrence: measured by the Assessment of Survivor Concerns - Cancer Worry subscale (ASC-CW) (Appendix H) * Cost-effectiveness: incremental costs and effectiveness will be determined: • Utility measure: EQ-5D-5L questionnaire (Appendix I) • Intramural costs: assessed by review of patient records • Extramural costs: assessed by a selection of relevant questions from the Medical Consumption Questionnaire (iMCQ) form the institute of Medical Technology Assessment. (Appendix J) o Questions 14, 15 and 18 - 31 are omitted from the original questionnaire. * Survival: both overall and cancer-specific, calculated from the date of surgical resection to the date of death or last follow-up. * Relation between coping style and follow-up preferences: measured by the Threatening Medical Situations Inventory (TMSI) (Appendix K) * Satisfaction of the patient-led home-based follow-up by a two-item questionnaire at the last follow-up (Appendix L) | — |
Countries
Netherlands
Outcome results
None listed