Follow-up After Surgery for Testicular Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
145 Participants
are grouped into 4 trial groupsGroup A: Non-seminomatous germ cell tumours, stage I low risk
Group B: Non-seminomatous germ cell tumours, stage I high risk
Group C: Seminomatous germ cell tumours (after chemotherapy) with complete remission.
Group D: Non-seminomatous germ cell tumours (after chemotherapy) with complete remission.
Trial outcomes
Primary outcomes
1
Successful implementation
Patient-led follow-up will be considered successful if the used optional follow up rate is below 75%.
Time frame
Year 8 (after the last follow-up moment of the last included patient)Secondary outcomes
1
Successful home-based sampling
Defined as 25% or more of all scheduled or optional tumour marker assessments actually performed in blood collected by the patients themselves using the self-administered blood-sampling kit
Time frame
Year 82
Quality of life of testicular cancer patients
Measured by the EORTC Core Quality of Life questionnaire (QLQ-C30). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.
Time frame
Year 83
Health-related quality of life
Measured by the EORTC Quality of Life Questionnaire - Testicular Cancer Module (EORTC QLQ-TC26). All scales and single-item measures range from 0-100 and are calculated using their respective formulas. Higher scores mean a better outcome.
Time frame
Year 84
Momentary quality of life
Measured by ecological momentary assessment using the Global health status of the EORTC QLQ-C30. The 2 items are scored on a Likert-scale from 1 to 7. Higher scores mean a better outcome.
Time frame
Year 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov