This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.
A prospective observational cohort study including two groups. Hypothyroid group: Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Control group: Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period. Association between thyroid status and bio signals will be investigated.
Study Type
OBSERVATIONAL
Enrollment
45
All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
physical activity (steps)
steps data measured by wearable device, collected and recorded in 1 min increment
Time frame: throughout the study period average 4 months
heart rate (beats)
heart rate data measured by wearable device, collected and recorded in 1 min increment
Time frame: throughout the study period average 4 months
free T4 level (ng/dL)
thyroid hormone level
Time frame: baseline (visit 1)
free T4 level (ng/dL)
thyroid hormone level
Time frame: after 2 to 3 months (visit 2)
free T4 level (ng/dL)
thyroid hormone level
Time frame: after 3 to 4 months (visit 3)
Zulewski hypothyroidism score ( point)
Scoring system to evaluate hypothyroid symptoms and signs
Time frame: baseline (visit 1)
Zulewski hypothyroidism score ( point)
Scoring system to evaluate hypothyroid symptoms and signs
Time frame: after 2 to 3 months (visit 2),
Zulewski hypothyroidism score ( point)
Scoring system to evaluate hypothyroid symptoms and signs
Time frame: after 3 to 4 months (visit 3)
TSH level (mIU/L)
thyroid stimulating hormone level
Time frame: baseline (visit 1)
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TSH level (mIU/L)
thyroid stimulating hormone level
Time frame: after 2 to 3 months (visit 2)
TSH level (mIU/L)
thyroid stimulating hormone level
Time frame: after 3 to 4 months (visit 3)