Hypothyroidism, Thyroid, Thyroid Cancer
Conditions
Keywords
Decision support tool, Patient-centered dosage, thyroidectomy, levothyroxine
Brief summary
Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.
Interventions
Patients in the intervention groups are given the option to use the decision support tool when adjusting the levothyroxine dose after total thyroidectomy. Levothyroxine therapy is not a part of the intervention, as all patients receive this therapy regardless of study participation.
Sponsors
SINTEF Health Research
Helseapps
Norinnova
Helse Nord
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals
Exclusion criteria
* Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients at biochemical target | Outcome is measured at 8 weeks, 6 months and 12 months post surgery | Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to biochemical target | Measured at 18 months after surgery | Time to biochemical target is reached measured in days. Day 0 is day of surgery |
| Distance from biochemical target | Measured at 8 weeks post surgery | Distance measured in TSH units. |
| Patient reported outcome - ThyPRO39 questionnaire | Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery | Patient reported outcomes measured by the validated questionnaire ThyPRO39. The ThyPRO39 questionnaire consist of 12 scales that covers physical symptoms (goiter, eye symptoms, hypo- and hyperthyroid symptoms), cosmetic appearance, physical, mental and social well-being and function. Each item is rated on a 0-4 scale from 0 = no symptoms/problems to 4 = Severe symptoms/problems. The average score of items in a scale is divided by four and multiplied by 100 to yield thirteen 0-100 scales, with higher scores indicating worse health status. The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups. |
| Patient reported outcome - RAND-36 questionnaire | Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery | Rand-36 is the Norwegian translation of the SF-36 version 1.2. The questionnaire consists of 36 items, grouped into eight multi-item scales that measure physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The scores can also be summarized into two summary scores for overall physical and mental health. Items scores will be transformed to 0-100 point scales (0=worst, 100=best) using the SF-36 scoring algorithm The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups. |
| Abscence from work | Measured at18 months after surgery | Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry |
Countries
Norway
Contacts
Primary ContactVegard Brun, PhD
Backup ContactSolveig Brun, cand.med
Outcome results
None listed