Clinical trial NCT05670938: Follow-up After Surgery for Testicular Cancer
Official title: Follow-up After Surgery for Testicular Cancer: the Prospective, Single Centre FUTURE-testis Implementation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Cancer
Testicular Germ Cell Tumor
Quality of Life
Keywords: Follow-up
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 145
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are 18 years or older who received curative intent surgical treatment for testicular cancer, and who (will) undergo postoperative surveillance are eligible. Patients can be included up to 3 months after curative treatment.

Brief summary: 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.

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

Primary outcomes:
measure: Successful implementation
timeFrame: Year 8 (after the last follow-up moment of the last included patient)
Secondary outcomes:
measure: Successful home-based sampling
timeFrame: Year 8
measure: Quality of life of testicular cancer patients
timeFrame: Year 8
measure: Health-related quality of life
timeFrame: Year 8
measure: Momentary quality of life
timeFrame: Year 8
measure: Anxiety
timeFrame: Year 8
measure: Fear of cancer recurrence
timeFrame: Year 8
measure: Cost-effectiveness of a patient-led home-based follow-up
timeFrame: Year 8
measure: Relation between coping style and follow-up preferences
timeFrame: Year 8
measure: Satisfaction of the patient-led home-based follow-up
timeFrame: Year 8
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Dirk J. Grünhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: