Follow-up After Surgery for Testicular Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Testicular Cancer, Testicular Germ Cell Tumor, Quality of Life. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
Overview
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.
Detailed description
Testicular cancer represents 1% of male neoplasms and 5% of all urological tumours. In 2021, 828 new patients in the Netherlands were diagnosed with testicular cancer. It is the most commonly diagnosed cancer among young men aged 20-39 years in the Netherlands and incidence is rising. Follow-up after treatment of testicular cancer consists of tumour marker assessment during hospital visits and multiple types of imaging at certain time points. Frequent hospital visits have significant impact on patients' lives, as in-hospital visits evoke distress around the time of visits. Home-based follow-up could be beneficial in terms of patients' well-being and societal cost-effectiveness. Furthermore, during the COVID-19 pandemic hospital visitations are minimized to decrease the chance of COVID-19 exposure. Home-based blood sampling will allow patients to stay home and avoid crowded areas such as public transport and the hospital.
Efforts to improve the current standard of follow-up in patients with testicular cancer should focus on ameliorating quality of life and cost-effectiveness. It provides an opportunity to support patients emotionally, to evaluate treatment effects and complications, and to inform them on their individual prognosis. This is especially true considering the growing importance of value-based healthcare and patient reported outcomes in medicine. The investigators therefore propose a patient-led home-based follow-up approach. This follow-up strategy primarily consists of tumour marker level monitoring at home and imaging performed in-hospital, but additional counselling/diagnostic testing remains possible if desired by patients. In this way the investigators hope to meet the individual needs of patients during follow-up and to improve quality of life outcomes, while achieving equal or greater societal cost-effectiveness.
Primary outcome measures
- Successful implementation [Time frame: Year 8 (after the last follow-up moment of the last included patient)]
Secondary outcome measures (9)
- Successful home-based sampling [Time frame: Year 8]
- Quality of life of testicular cancer patients [Time frame: Year 8]
- Health-related quality of life [Time frame: Year 8]
- Momentary quality of life [Time frame: Year 8]
- Anxiety [Time frame: Year 8]
- Fear of cancer recurrence [Time frame: Year 8]
- Cost-effectiveness of a patient-led home-based follow-up [Time frame: Year 8]
- Relation between coping style and follow-up preferences [Time frame: Year 8]
- Satisfaction of the patient-led home-based follow-up [Time frame: Year 8]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT05670938 · NL78539.078.21