Primary Objective: The primary outcome of this study is successful implementation of home-based blood sampling. The success criteria is that 25% or more of the blood assessments are actually performed at home by the patients themselves using a self-…
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Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Testicular cancer represents 1% of male neoplasms and 5% of all urological
tumours. Last year 828 new patients in the Netherlands were diagnosed with
testicular cancer (http://www.cijfersoverkanker.nl/). Testicular cancer is the
most commonly diagnosed cancer among young men aged 20-39 years in the
Netherlands and the incidence is still rising.
Postoperative surveillance pursues the detection of relapse and metastases in
an early, asymptomatic, and treatable stage. The current national standard of
care therefore consists of an in-hospital multimodality follow-up, using
imaging (CT scan, X-ray and ultrasound), hospital consultation, and blood
tumour marker assessment of α-fetoprotein (AFP), human chorionic gonadotropin
(hCG), and lactate dehydrogenase (LDH). Elevated serum tumour markers indicate
the likely presence of recurrent disease. Some hospital visits only consist of
blood assessment.
It is important to note that frequent hospital visits have significant impact
on patients* lives, as they can evoke distress. A way to optimize follow-up
would be to improve the patient*s quality of life, and may be achieved by a
patient-controlled follow-up scheme based on monitoring at home. This follow-up
strategy primarily consists of AFP and hCG level monitoring at home, but
additional counseling/diagnostic testing remains possible if desired by
patients. In this way we 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. Furthermore, during the COVID-19 pandemic
hospital visitations are minimalized to decrease the chance of COVID-19
exposure. Home based blood sampling will allow patients to stay home and avoid
crowds in places such as public transport and the hospital.
Study objective
Primary Objective:
The primary outcome of this study is successful implementation of home-based
blood sampling. The success criteria is that 25% or more of the blood
assessments are actually performed at home by the patients themselves using a
self-administered blood-sampling kit.
Secondary Objective(s):
The secondary objectives of this study are:
• Successful implementation of patient-led home-based surveillance after
treatment of testicular cancer. For which succesful is defined as 75% or less
of the optional follow-up moments being utilized for patients treated for
non-seminoma, stage I low risk.
• To compare the quality of life with an in-hospital standard of care related
cohort
• To evaluate anxiety
• To evaluate fear of cancer recurrence
• To evaluate overall and cancer-specific survival
• To determine and compare the cost-effectiveness of follow-up
• To predict follow-up preferences based on patients* coping style
• To measure patient satisfaction at the end of the follow-up period
Study design
The FUTURE testis study is a single-center prospective implementation study of
a patient-directed follow-up in the home setting after curative treatment for
testicular cancer. Follow-up takes place up to five years after treatment.
Follow-up takes place according to the current guidelines in the Erasmus MC,
based on the European guidelines. In principle, the optional follow up moments
takes place at home with blood sampling, while the actual tumor marker
measurements are centralized and the interpretation of the results is done by
the treating physician. LDH is the least specific and sensitive marker in
testicular cancer and, additionally, a marker sensitive to handling and
transport. Therefore, patients with an aberrant level of LDH pre-operatively
are excluded and LDH levels of included patients are measured only in the
hospital setting. This means that when patients travel to the hospital for
radiological imaging, blood sampling will be performed at the hospital for all
three tumour markers (AFP, hCG and LDH). The frequency of blood draws depends
on the testicular cancer subtype. One subgroup (Non-seminoma, stage 1 low risk)
is able to choose additional follow-up moments. In the hospital an evaluation
is only performed in case of abnormal tumor marker values **or if desired by
the patient (with normal tumor marker values). Use of medical imaging is
performed according to the current guidelines at ErasmusMC. The frequency of
tumor marker measurements and hospital evaluations cannot exceed the maximum
number in the current guidelines in Erasmus MC, unless clinically indicated
(eg. tumor marker elevation or symptoms). The desired frequency can be changed
by the patient at any time.
Study burden and risks
We hypothesize that a patient-led follow-up with home-based tumour marker
sampling can be implemented successfully. In addition, we hypothesize that such
an approach improves quality of life outcomes and reduces anxiety and fear of
cancer recurrence when compared with the contemporary in-hospital approach.
These hypotheses were substantiated by way of systematic patient-interviews. We
also expect the home based approach to achieve an equal or greater
cost-effectiveness.
This study will provide valuable insights in the questions surrounding
follow-up, mainly whether current follow-up practices based on frequent
hospital visitations can be replaced by a more modern, home based follow-up
with an emphasis on shared-decision making. Therefore, our aim is to identify
an optimal, patient-tailored way of monitoring patients after curative
treatment of testicular cancer. An individualized home based surveillance
approach fits well in the current era of value based healthcare and patient
reported outcomes. The results of this study will be used to create evidence
based guidelines for long-term surveillance of these patients and could
potentially lead to similar studies and approaches in other suitable patient
populations.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL78539.078.21 |