This study aims to detect differences in sick leave time, associated costs and quality of life between differentiated thyroid cancer patients treated in either a fast-track protocol or a traditional longer time interval between total thyroidectomy…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Days of sick leave reported from time of surgery
Secondary outcome
Quality of life
Costs associated with productivity at work
Societal costs associated with absence from work
Background summary
The initial treatment of patients with differentiated thyroid cancer consists
of total thyroidectomy followed by thyroid remnant radioiodine ablative therapy
(RIT). For successful RIT, elevated TSH levels are necessary. Before the
introduction of recombinant human TSH (rhTSH) patients were withheld thyroid
hormone substitution therapy for 4 weeks after surgery. Nowadays RIT after
rhTSH is possible, preventing thyroid hormone withdrawal and subsequent
symptoms of hypothyroidism in these patients. Results of RIT after thyroid
hormone withdrawal and rhTSH stimulation are comparable. The availability of
rhTSH resulted in the possibility to plan the ablation directly after the
surgery.
We hypothesize that with the availability of rhTSH the waiting period post
operatively can be shortened and that with a fast track
protocol treatment of thyroid cancer patients will result in less sick-leave
time. Secondly, patients will have a higher quality of life
during the treatment, the costs of the fast-track protocol for society will be
less.
Study objective
This study aims to detect differences in sick leave time, associated costs and
quality of life between differentiated thyroid cancer patients treated in
either a fast-track protocol or a traditional longer time interval between
total thyroidectomy and rhTSH aided RIT.
Study design
Randomized prospective multicenter study
Intervention
58 patients will be randomly allocated to either A) thyroidectomy directly
followed by RIT (fast-track protocol (n=29), or B)
thyroidectomy followed by a 4 week waiting period before RIT (standard
treatment protocol (n=29)).
Study burden and risks
The risk of this study for the subjects will be minimal because the
intervention treatment protocol is in general identical to the standard
treatment according to the national guidelines. The subjects allocated to the
intervention group (group 1) will benefit from the new *fast-track* protocol.
Subjects in the standard treatment group (group 2) will not have a different
treatment compared to not participating patients.
The burden consists of extra questionnaires and a diary. This is considered to
be minimally.
The result of this study will substantially reduce both the duration of the
treatment for patients with DTC as the costs of this treatment for society in
the future. This justifies the minimal extra burden on the subjects included in
this study.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
1. Patients with differentiated thyroid cancer, stage T1-3N0-1M0-x
2. Patient planned for total or completion thyroidectomy
3. Paid job; at least 12 hours per week
4. Capable of understanding Dutch questionnaires and keeping a diary
Exclusion criteria
1. Pregnant or breastfeeding patients
2. T4 (i.e. tumor expansion in vital structures) or M1 tumors
3. Contrast enhanced CT performed < 4 months prior to inclusion
4. Hypersensitivity to bovine serum albumin, rhTSH or to any other of the excipients
5. Dialysis-dependent end stage renal disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41880.041.13 |
| OMON | NL-OMON21104 |