Follow-up After Surgery for Testicular Cancer

Официальное название

Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Successful implementation [Срок оценки: Year 8 (after the last follow-up moment of the last included patient)]

Вторичные конечные точки (9)

• Successful home-based sampling [Срок оценки: Year 8]
• Quality of life of testicular cancer patients [Срок оценки: Year 8]
• Health-related quality of life [Срок оценки: Year 8]
• Momentary quality of life [Срок оценки: Year 8]
• Anxiety [Срок оценки: Year 8]
• Fear of cancer recurrence [Срок оценки: Year 8]
• Cost-effectiveness of a patient-led home-based follow-up [Срок оценки: Year 8]
• Relation between coping style and follow-up preferences [Срок оценки: Year 8]
• Satisfaction of the patient-led home-based follow-up [Срок оценки: Year 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Идентификаторы

NCT: NCT05670938 · NL78539.078.21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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